Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05677490
Other study ID # A022102
Secondary ID NCI-2022-08569
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 23, 2023
Est. completion date November 8, 2028

Study information

Verified date August 2023
Source Alliance for Clinical Trials in Oncology
Contact Aishwarya Vijendran
Phone 773-834-9613
Email aishwaryav@bsd.uchicago.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.


Description:

PRIMARY OBJECTIVE: I. To determine if overall survival (OS) is improved in patients who received mFOLFIRINOX +/- nivolumab in comparison to FOLFOX +/- nivolumab as first-line chemotherapy for metastatic gastroesophageal adenocarcinoma. SECONDARY OBJECTIVES: I. To compare other indices of efficacy, including progression-free survival, objective response rates and duration of response between both treatment arms. II. To evaluate safety and tolerability associated with treatment in each of the treatment arms. III. To evaluate the proportion of patients receiving second line of therapy in both arms. IV. To evaluate tolerability of the treatment in both arms using Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE). EXPLORATORY OBJECTIVES: I. Exploratory correlative markers will also be measured and evaluated within and between arms to better assess mechanisms and prognostic impact of markers on impact. These will include baseline PD-L1 combined positive score (CPS) and cell free deoxyribonucleic acid (cfDNA) before and after treatment. II. To evaluate and assess the feasibility and compliance associated with not centrally collecting perceived attribution of protocol treatment to reported adverse events. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive fluorouracil intravenously (IV), leucovorin calcium IV, oxaliplatin IV, and irinotecan IV on study and nivolumab IV as clinically indicated. Patients undergo magnetic resonance imaging (MRI) and a computed tomography (CT) scan throughout the trial. Patients may also undergo blood sample collection on study. ARM II: Patients receive fluorouracil IV, leucovorin calcium IV, and oxaliplatin IV on study and nivolumab IV as clinically indicated. Patients undergo MRI and a CT scan throughout the trial. Patients may also undergo blood sample collection on study.


Recruitment information / eligibility

Status Recruiting
Enrollment 382
Est. completion date November 8, 2028
Est. primary completion date November 8, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologic documentation: HER2 negative adenocarcinoma as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (Bartley et al., Journal of Clinical Oncology [JCO] 2017) with known PD-L1 CPS (Any CPS is allowed, but should be known prior to registration) - Stage: unresectable or metastatic - Tumor site: esophagus, gastroesophageal junction, or stomach - Measurable disease or non-measurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - No prior treatment for unresectable or metastatic disease - Prior neoadjuvant or adjuvant cytotoxic chemotherapy or adjuvant immunotherapy is allowed as long as it was completed at least 1 year prior to registration - Age >= 18 years - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 - Absolute neutrophil count (ANC) >= 1,500/mm^3 - Platelet count >= 100,000/mm^3 - Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/min - Total bilirubin =< 1.5 x ULN - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (in patients with liver metastasis: =< 5 x ULN if clearly attributable to liver metastases) - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial - Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following: - On effective anti-retroviral therapy - Undetectable HIV viral load by standard clinical assay =< 6 months of registration - Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better - Patients who will receive nivolumab in addition to chemotherapy must not have any contraindications to immune checkpoint inhibitors - Patients must not have active autoimmune disease that has required systemic treatment within 6 months prior to registration. Patients are permitted to receive immunotherapy if they have vitiligo, type I diabetes, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event) - Patients must not have a condition requiring systemic treatment with either corticosteroids (>10mg/day prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids and adrenal replacement doses (=< 10mg/day prednisone equivalent) are permitted - Patients must not have a history of noninfectious pneumonitis requiring steroids - Patients with prior immune mediated adverse events related to immunotherapy that resulted in permanent treatment discontinuation with these agents are ineligible - This study includes the use of the mandatory patient completed measure, PRO-CTCAE. For this study the PRO-CTCAE is available in English, Spanish, Korean, Chinese (Simplified), and Russian, hence patients must be able to speak, understand and read in these languages. Ad-hoc translation of patient-reported measures is not permitted Exclusion Criteria: - Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects * Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =< 7 days prior to registration is required - No known Gilbert's syndrome or known homozygosity for UGAT1A1*28 polymorphism - No baseline grade >= 2 peripheral neuropathy, neurosensory toxicity, or neuromotor toxicity per CTCAE version (v) 5.0 regardless of causality - No medical condition such as uncontrolled infection or uncontrolled diabetes mellitus which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient - No untreated, symptomatic brain metastasis. Patients with treated brain metastases are eligible if the following criteria are met: 1) follow-up brain imaging done at least in 4 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression and 2) the patient no longer requires steroids, or is on a stable steroid dose for more than four weeks - No allogeneic tissue/organ transplant

Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Advanced Esophageal Adenocarcinoma
  • Advanced Gastric Adenocarcinoma
  • Advanced Gastroesophageal Junction Adenocarcinoma
  • Clinical Stage III Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage III Gastric Cancer AJCC v8
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage IV Gastric Cancer AJCC v8
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Esophageal Neoplasms
  • Metastatic Esophageal Adenocarcinoma
  • Metastatic Gastric Adenocarcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Stomach Neoplasms
  • Unresectable Esophageal Adenocarcinoma
  • Unresectable Gastric Adenocarcinoma
  • Unresectable Gastroesophageal Junction Adenocarcinoma

Intervention

Drug:
Fluorouracil
Given IV
Leucovorin Calcium
Given IV
Oxaliplatin
Given IV
Irinotecan
Given IV
Biological:
Nivolumab
Given IV
Procedure:
Magnetic Resonance Imaging
Undergo MRI
Computed Tomography
Undergo a CT Scan
Biospecimen Collection
Undergo blood sample collection
Other:
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
Puerto Rico Cancer Center-Metro Medical Center Bayamon Bayamon
Puerto Rico Doctors Cancer Center Manati
Puerto Rico Centro Comprensivo de Cancer de UPR San Juan
Puerto Rico PROncology San Juan
Puerto Rico San Juan City Hospital San Juan
Puerto Rico San Juan Community Oncology Group San Juan
United States Avera Cancer Institute-Aberdeen Aberdeen South Dakota
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Hickman Cancer Center Adrian Michigan
United States Riverwood Healthcare Center Aitkin Minnesota
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Saint Anthony's Health Alton Illinois
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Oncology and Hematology LLC Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Associates in Radiation Medicine Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Anchorage Radiation Therapy Center Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States Kaiser Permanente-Deer Valley Medical Center Antioch California
United States Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
United States PCR Oncology Arroyo Grande California
United States Duluth Clinic Ashland Ashland Wisconsin
United States Northwest Wisconsin Cancer Center Ashland Wisconsin
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States Rush - Copley Medical Center Aurora Illinois
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Flaget Memorial Hospital Bardstown Kentucky
United States Advocate Good Shepherd Hospital Barrington Illinois
United States Essentia Health - Baxter Clinic Baxter Minnesota
United States McLaren Cancer Institute-Bay City Bay City Michigan
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States Nebraska Medicine-Bellevue Bellevue Nebraska
United States Overlake Medical Center Bellevue Washington
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Saint Charles Health System Bend Oregon
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Elizabeth Boardman Hospital Boardman Ohio
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States McFarland Clinic - Boone Boone Iowa
United States Boston Medical Center Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Boulder Community Foothills Hospital Boulder Colorado
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Essentia Health Saint Joseph's Medical Center Brainerd Minnesota
United States Cox Cancer Center Branson Branson Missouri
United States Harrison Medical Center Bremerton Washington
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Steward Saint Elizabeth's Medical Center Brighton Massachusetts
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States Fairview Ridges Hospital Burnsville Minnesota
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Cambridge Medical Center Cambridge Minnesota
United States Cleveland Clinic Mercy Hospital Canton Ohio
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Mercy Cancer Center ?? Carmichael Carmichael California
United States Mercy San Juan Medical Center Carmichael California
United States Caro Cancer Center Caro Michigan
United States Carson Tahoe Regional Medical Center Carson City Nevada
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Rocky Mountain Cancer Centers - Centennial Centennial Colorado
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Providence Regional Cancer System-Centralia Centralia Washington
United States Saint Mary's Hospital Centralia Illinois
United States Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania
United States Medical University of South Carolina Charleston South Carolina
United States West Virginia University Charleston Division Charleston West Virginia
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Cheyenne Regional Medical Center-West Cheyenne Wyoming
United States Advocate Illinois Masonic Medical Center Chicago Illinois
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Cancer Institute Clackamas Clinic Clackamas Oregon
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States McLaren Cancer Institute-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Wake Forest University at Clemmons Clemmons North Carolina
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Memorial Hospital North Colorado Springs Colorado
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States Saint Francis Cancer Center Colorado Springs Colorado
United States UCHealth Memorial Hospital Central Colorado Springs Colorado
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Mercy Hospital Coon Rapids Minnesota
United States Bay Area Hospital Coos Bay Oregon
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Heartland Oncology and Hematology LLP Council Bluffs Iowa
United States Jennie Edmundson Memorial Hospital Council Bluffs Iowa
United States Northwest Cancer Center - Main Campus Crown Point Indiana
United States AMG Crystal Lake - Oncology Crystal Lake Illinois
United States Carle at The Riverfront Danville Illinois
United States Dayton Blood and Cancer Center Dayton Ohio
United States Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Essentia Health - Deer River Clinic Deer River Minnesota
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Grady Memorial Hospital Delaware Ohio
United States Colorado Blood Cancer Institute Denver Colorado
United States National Jewish Health-Main Campus Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Rocky Mountain Cancer Centers-Rose Denver Colorado
United States Rose Medical Center Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States The Women's Imaging Center Denver Colorado
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes Minnesota
United States Illinois CancerCare-Dixon Dixon Illinois
United States Advocate Good Samaritan Hospital Downers Grove Illinois
United States Columbus Oncology and Hematology Associates Dublin Ohio
United States Dublin Methodist Hospital Dublin Ohio
United States Kaiser Permanente Dublin Dublin California
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Mercy Medical Center Durango Colorado
United States Southwest Oncology PC Durango Colorado
United States Northwest Oncology LLC Dyer Indiana
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Pocono Medical Center East Stroudsburg Pennsylvania
United States Fairview Southdale Hospital Edina Minnesota
United States Swedish Cancer Institute-Edmonds Edmonds Washington
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Advocate Sherman Hospital Elgin Illinois
United States Mercy Cancer Center - Elk Grove Elk Grove California
United States Christiana Care - Union Hospital Elkton Maryland
United States Essentia Health - Ely Clinic Ely Minnesota
United States Mountain Blue Cancer Care Center - Swedish Englewood Colorado
United States Rocky Mountain Cancer Centers - Swedish Englewood Colorado
United States Swedish Medical Center Englewood Colorado
United States The Melanoma and Skin Cancer Institute Englewood Colorado
United States Illinois CancerCare-Eureka Eureka Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States Inova Schar Cancer Institute Fairfax Virginia
United States Inova Fairfax Hospital Falls Church Virginia
United States Essentia Health Cancer Center-South University Clinic Fargo North Dakota
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Medical Center Fargo Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Sanford South University Medical Center Fargo North Dakota
United States Southpointe-Sanford Medical Center Fargo Fargo North Dakota
United States Farmington Health Center Farmington Utah
United States Parkland Health Center - Farmington Farmington Missouri
United States Weisberg Cancer Treatment Center Farmington Hills Michigan
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McLaren Cancer Institute-Flint Flint Michigan
United States Cancer Care and Hematology-Fort Collins Fort Collins Colorado
United States Poudre Valley Hospital Fort Collins Colorado
United States McFarland Clinic - Trinity Cancer Center Fort Dodge Iowa
United States Regional Cancer Center-Lee Memorial Health System Fort Myers Florida
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Essentia Health - Fosston Fosston Minnesota
United States Dana-Farber Cancer Institute at Foxborough Foxboro Massachusetts
United States Beebe South Coastal Health Campus Frankford Delaware
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Kaiser Permanente-Fremont Fremont California
United States Queens Medical Associates PC Fresh Meadows New York
United States Fresno Cancer Center Fresno California
United States Kaiser Permanente-Fresno Fresno California
United States Unity Hospital Fridley Minnesota
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Central Ohio Breast and Endocrine Surgery Gahanna Ohio
United States University of Florida Health Science Center - Gainesville Gainesville Florida
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Central Care Cancer Center - Garden City Garden City Kansas
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States National Jewish Health-Western Hematology Oncology Golden Colorado
United States SCL Health Cancer Centers of Colorado - Lutheran Medical Center Golden Colorado
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States UCHealth Greeley Hospital Greeley Colorado
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Northwell Health Cancer Institute at Huntington Greenlawn New York
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States Miami Valley Cancer Care and Infusion Greenville Ohio
United States Wayne Hospital Greenville Ohio
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Mount Carmel Grove City Hospital Grove City Ohio
United States Zangmeister Center Grove City Grove City Ohio
United States Ingalls Memorial Hospital Harvey Illinois
United States HaysMed University of Kansas Health System Hays Kansas
United States Essentia Health-Hayward Clinic Hayward Wisconsin
United States Advocate South Suburban Hospital Hazel Crest Illinois
United States Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada
United States GenesisCare USA - Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States Las Vegas Urology - Green Valley Henderson Nevada
United States Las Vegas Urology - Pebble Henderson Nevada
United States OptumCare Cancer Care at Seven Hills Henderson Nevada
United States Urology Specialists of Nevada - Green Valley Henderson Nevada
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States Northwest Cancer Center - Hobart Hobart Indiana
United States Saint Mary Medical Center Hobart Indiana
United States Kaiser Permanente Moanalua Medical Center Honolulu Hawaii
United States Saint Catherine Hospital Indianapolis Indiana
United States Essentia Health - International Falls Clinic International Falls Minnesota
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States Essentia Health - Jamestown Clinic Jamestown North Dakota
United States McFarland Clinic - Jefferson Jefferson Iowa
United States Capital Region Southwest Campus Jefferson City Missouri
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Truman Medical Centers Kansas City Missouri
United States CHI Health Good Samaritan Kearney Nebraska
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Kingman Regional Medical Center Kingman Arizona
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Northwell Health/Center for Advanced Medicine Lake Success New York
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States Saint Anthony Hospital Lakewood Colorado
United States Fairfield Medical Center Lancaster Ohio
United States Karmanos Cancer Institute at McLaren Greater Lansing Lansing Michigan
United States Sparrow Hospital Lansing Michigan
United States McLaren Cancer Institute-Lapeer Region Lapeer Michigan
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Ann M Wierman MD LTD Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States GenesisCare USA - Fort Apache Las Vegas Nevada
United States GenesisCare USA - Las Vegas Las Vegas Nevada
United States GenesisCare USA - Vegas Tenaya Las Vegas Nevada
United States Hope Cancer Care of Nevada Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center Las Vegas Nevada
United States Las Vegas Prostate Cancer Center Las Vegas Nevada
United States Las Vegas Urology - Cathedral Rock Las Vegas Nevada
United States Las Vegas Urology - Pecos Las Vegas Nevada
United States Las Vegas Urology - Smoke Ranch Las Vegas Nevada
United States Las Vegas Urology - Sunset Las Vegas Nevada
United States OptumCare Cancer Care at Charleston Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States OptumCare Cancer Care at MountainView Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States University Cancer Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Urology Specialists of Nevada - Central Las Vegas Nevada
United States Urology Specialists of Nevada - Northwest Las Vegas Nevada
United States Urology Specialists of Nevada - Southwest Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Beebe Medical Center Lewes Delaware
United States Saint Joseph Hospital Lexington Kentucky
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States AMG Libertyville - Oncology Libertyville Illinois
United States Condell Memorial Hospital Libertyville Illinois
United States Saint Rita's Medical Center Lima Ohio
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States Littleton Adventist Hospital Littleton Colorado
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Saint Joseph London London Kentucky
United States The Dana-Farber Cancer Institute at Londonderry Londonderry New Hampshire
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States PeaceHealth Saint John Medical Center Longview Washington
United States Medical Center of the Rockies Loveland Colorado
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States OhioHealth Mansfield Hospital Mansfield Ohio
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States OhioHealth Marion General Hospital Marion Ohio
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States McFarland Clinic - Marshalltown Marshalltown Iowa
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Aspirus Medford Hospital Medford Wisconsin
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States Dana Farber-Merrimack Valley Methuen Massachusetts
United States Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford Massachusetts
United States Aurora Cancer Care-Milwaukee Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Kaiser Permanente-Modesto Modesto California
United States Trinity Medical Center Moline Illinois
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Monticello Cancer Center Monticello Minnesota
United States Essentia Health - Moose Lake Clinic Moose Lake Minnesota
United States McLaren Cancer Institute-Macomb Mount Clemens Michigan
United States Northern Westchester Hospital Mount Kisco New York
United States Saint Joseph Mount Sterling Mount Sterling Kentucky
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States The Community Hospital Munster Indiana
United States Women's Diagnostic Center - Munster Munster Indiana
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Providence Queen of The Valley Napa California
United States Mount Carmel New Albany Surgical Hospital New Albany Ohio
United States UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Lenox Hill Hospital New York New York
United States Manhattan Eye Ear and Throat Hospital New York New York
United States NYP/Weill Cornell Medical Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Delaware Clinical and Laboratory Physicians PA Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Newark Radiation Oncology Newark Ohio
United States Providence Newberg Medical Center Newberg Oregon
United States Carle Cancer Institute Normal Normal Illinois
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Advocate Christ Medical Center Oak Lawn Illinois
United States Kaiser Permanente Oakland-Broadway Oakland California
United States Kaiser Permanente-Oakland Oakland California
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Health Cancer Center Olathe Kansas
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Omaha Nebraska
United States Nebraska Medicine-Village Pointe Omaha Nebraska
United States Nebraska Methodist Hospital Omaha Nebraska
United States Oncology Associates PC Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Providence Willamette Falls Medical Center Oregon City Oregon
United States University of Chicago Medicine-Orland Park Orland Park Illinois
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Mercy Health - Paducah Medical Oncology and Hematology Paducah Kentucky
United States Hope Cancer Care of Nevada-Pahrump Pahrump Nevada
United States Midlands Community Hospital Papillion Nebraska
United States Essentia Health - Park Rapids Park Rapids Minnesota
United States Advocate Lutheran General Hospital Park Ridge Illinois
United States Parker Adventist Hospital Parker Colorado
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Mercy Health Perrysburg Cancer Center Perrysburg Ohio
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States McLaren Cancer Institute-Northern Michigan Petoskey Michigan
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States Freeman Physician Group of Pittsburg Pittsburg Kansas
United States 21st Century Oncology-Pontiac Pontiac Michigan
United States Hope Cancer Center Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States McLaren-Port Huron Port Huron Michigan
United States Jefferson Healthcare Port Townsend Washington
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Southern Ohio Medical Center Portsmouth Ohio
United States Fairview Northland Medical Center Princeton Minnesota
United States Illinois CancerCare-Princeton Princeton Illinois
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California
United States Saint Charles Health System-Redmond Redmond Oregon
United States Kaiser Permanente- Marshall Medical Offices Redwood City California
United States Beebe Health Campus Rehoboth Beach Delaware
United States Radiation Oncology Associates Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Valley Medical Center Renton Washington
United States Kaiser Permanente-Richmond Richmond California
United States Reid Health Richmond Indiana
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mercy Cancer Center - Rocklin Rocklin California
United States Rohnert Park Cancer Center Rohnert Park California
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Kaiser Permanente-Roseville Roseville California
United States The Permanente Medical Group-Roseville Radiation Oncology Roseville California
United States Kaiser Permanente Downtown Commons Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States Mercy Cancer Center - Sacramento Sacramento California
United States South Sacramento Cancer Center Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Salina Regional Health Center Salina Kansas
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States University of Utah Sugarhouse Health Center Salt Lake City Utah
United States Kaiser Permanente-San Francisco San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
United States Kaiser San Rafael-Gallinas San Rafael California
United States Essentia Health Sandstone Sandstone Minnesota
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Mission Hope Medical Oncology - Santa Maria Santa Maria California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Providence Medical Foundation - Santa Rosa Santa Rosa California
United States Providence Santa Rosa Memorial Hospital Santa Rosa California
United States Swedish Medical Center-Ballard Campus Seattle Washington
United States Swedish Medical Center-Cherry Hill Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States PeaceHealth United General Medical Center Sedro-Woolley Washington
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Providence Regional Cancer System-Shelton Shelton Washington
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Phelps Memorial Hospital Center Sleepy Hollow New York
United States Kaiser Permanente Cancer Treatment Center South San Francisco California
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth Massachusetts
United States Essentia Health-Spooner Clinic Spooner Wisconsin
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Kaiser Permanente-Stockton Stockton California
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Aurora Medical Center in Summit Summit Wisconsin
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Essentia Health Saint Mary's Hospital - Superior Superior Wisconsin
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Sanford Thief River Falls Medical Center Thief River Falls Minnesota
United States National Jewish Health-Northern Hematology Oncology Thornton Colorado
United States Rocky Mountain Cancer Centers-Thornton Thornton Colorado
United States Mercy Health - Saint Anne Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States Dayton Physicians LLC - Troy Troy Ohio
United States Upper Valley Medical Center Troy Ohio
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States Carle Cancer Center Urbana Illinois
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
United States Kaiser Permanente-Vallejo Vallejo California
United States Northwest Cancer Center - Valparaiso Valparaiso Indiana
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Essentia Health Virginia Clinic Virginia Minnesota
United States Ridgeview Medical Center Waconia Minnesota
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Advanced Breast Care Center PLLC Warren Michigan
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Saint Joseph Warren Hospital Warren Ohio
United States Illinois CancerCare - Washington Washington Illinois
United States Mercy Hospital Washington Washington Missouri
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States Saint Ann's Hospital Westerville Ohio
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Wake Forest Baptist Health - Wilkes Medical Center Wilkesboro North Carolina
United States Rice Memorial Hospital Willmar Minnesota
United States Christiana Care Health System-Wilmington Hospital Wilmington Delaware
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Woodland Memorial Hospital Woodland California
United States Sanford Cancer Center Worthington Worthington Minnesota
United States Fairview Lakes Medical Center Wyoming Minnesota
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington
United States Providence Regional Cancer System-Yelm Yelm Washington
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Saint Elizabeth Youngstown Hospital Youngstown Ohio
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Other Exploratory correlative markers Exploratory correlative markers will also be measured and evaluated within and between arms to better assess mechanisms and prognostic impact of markers on impact. These will include baseline PD-L1 combined positive score and cell free deoxyribonucleic acid during the treatment. Up to 3 years
Other Incidence of adverse events Will evaluate the delinquency rate for the standard adverse event (AE) case report forms (CRFs) for this trial over the course of the trial and compare this to the proportion of patients with delinquent AE CRFs on other phase III trials conducted during the same time frame as this trial. up to 3 years
Other Feasibility and compliance of intervention Finally, we will also collect data related feasibility and compliance in term of the number of queries received by participating sites regarding questions on attribution collection as well as if any attribution is forcibly submitted using the comments fields. Up to 3 years
Primary Overall survival (OS) Will compare the distributions of OS between the two treatment arms to determine if patients treated with modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) (with or without nivolumab) have an OS benefit compared to those treated with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) (with or without nivolumab). Kaplan-Meier methodology will be used to estimate the distributions for the treatment arms. To compare the OS distributions between the two treatment arms, we will use a one-sided logrank test to evaluate if mFOLFIRINOX (with or without nivolumab) is superior to mFOLFOX (with or without nivolumab) based on an intention to treat analysis. The hazard ratio, median OS, and estimated OS rates at 1 and 2 years will be estimated along with corresponding 95% confidence intervals. Multivariable Cox proportional hazards models will also be used to assess the impact of treatment arm on OS when stratifying on the stratification factors. Up to 2 years from the time of randomization.
Secondary Progression-free survival (PFS) PFS will be evaluated as a time to event outcome and compared in a secondary manner between the two treatment arms. Patients who are alive and progression-free at their last evaluation will be censored at that time point. The time from registration to the time of documented progression and/or death, assessed up to 3 years
Secondary Overall response rate The best response achieved after initiation of therapy on protocol will also be assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and will be summarized by treatment arm. The overall response rate will be calculated as the number of patients who achieve a response (partial response, complete response) divided by the total number of patients randomized to the corresponding treatment arm. Up to 3 years
Secondary Duration of Response The time between each patient's best tumor response and progression (or date of last disease assessment for patients who die without progression or are lost to follow-up), assessed up to 3 years
Secondary Incidence of adverse events The toxicity and tolerability of each of these regimens will be evaluated and captured using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5, where the type and severity grade of each adverse event will be collected and tabulated within each of the treatment arms. Perceived attribution to study treatment will also be captured. Tolerability will further be assessed by summarizing the numbers of patients who require dose modifications or delays, and reasons for patients to go off treatment. Up to 3 years
Secondary Patient reported outcomes Patient-reported side effect assessments (Patient Reported Outcomes [PRO]-CTCAE) will also be collected before and during therapy and will be summarized within and compared between treatment arms. To evaluate between-arm differences in patient-reported symptomatic adverse events as assessed by the PRO-CTCAE, the frequency and proportion of patients with a maximum post-baseline score greater than 0 will be compared across arms using a chi^2 test or Fisher's exact test with a nominal significance level of alpha = 0.10. Similarly, the frequency and proportion of patients with a maximum post-baseline score greater than or equal to 3 will be compared across arms using a chi^2 test or Fisher's exact test with a nominal significance level of alpha = 0.10. At baseline, day 1 of cycles 1-8 and day 1 of each odd-numbered cycle thereafter
See also
  Status Clinical Trial Phase
Active, not recruiting NCT01142388 - Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer Phase 2
Active, not recruiting NCT03337087 - Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer Phase 1/Phase 2
Active, not recruiting NCT03641313 - Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresectable TP53 Mutant Gastric or Gastroesophageal Junction Cancer Phase 2
Recruiting NCT04781686 - Apatinib Plus Camrelizumab Combined With Docetaxel and S1 in First-line Treatment for Metastatic Gastric Cancer Phase 2
Not yet recruiting NCT05342389 - Camrelizumab Combined With Apatinib Versus Apatinib Alone in the Third-line Treatment of Metastatic Gastric Cancer Phase 2
Recruiting NCT05733000 - CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors Phase 2
Recruiting NCT05651594 - Propranolol in Combination With Pembrolizumab and Standard Chemotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Adenocarcinoma Phase 2
Recruiting NCT05269381 - Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04511039 - Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer Phase 1
Not yet recruiting NCT04921904 - Abemaciclib Plus Ramucirumab for Esophageal/Gastroesophageal Junction Ca Phase 1/Phase 2
Recruiting NCT04660760 - Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer Phase 2
Active, not recruiting NCT05555251 - BI-1607 in Combination With Trastuzumab in Subjects With HER2-positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04840264 - Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction Phase 2
Recruiting NCT06203600 - Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial Phase 2/Phase 3
Completed NCT02391038 - MLN0264 in Previously Treated Asian Patients With Advanced Gastrointestinal Carcinoma or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Guanylyl Cyclase C Phase 1/Phase 2
Completed NCT03395847 - Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Adenocarcinoma Early Phase 1
Active, not recruiting NCT03008278 - Olaparib and Ramucirumab in Treating Patients With Metastatic or Locally Recurrent Gastric or Gastroesophageal Junction Cancer That Cannot Be Removed by Surgery Phase 1/Phase 2
Recruiting NCT06329973 - Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer Phase 1/Phase 2
Recruiting NCT05041153 - Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma Early Phase 1
Recruiting NCT04007744 - Sonidegib and Pembrolizumab in Treating Patients With Advanced Solid Tumors Phase 1