Metastatic Gastroesophageal Junction Adenocarcinoma Clinical Trial
Official title:
Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma
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.
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 |
Country | Name | City | State |
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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 |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States, Puerto Rico,
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 |
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