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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03609216
Other study ID # A031701
Secondary ID NCI-2018-01531U1
Status Recruiting
Phase Phase 2
First received
Last updated
Start date August 1, 2018
Est. completion date February 2029

Study information

Verified date May 2024
Source Alliance for Clinical Trials in Oncology
Contact Gopa Iyer, MD
Phone 646-888-4737
Email iyerg@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, 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.


Description:

PRIMARY OBJECTIVES: I. To determine the 3-year event free survival, defined as the proportion of patients without invasive or metastatic recurrence following definitive gemcitabine hydrochloride (gemcitabine) and cisplatin (standard or dose-dense) chemotherapy in those patients whose pre-treatment transurethral resection of bladder tumor (TURBT) tumors harbor deleterious DDR gene alterations and who achieve < cT1 response to chemotherapy. SECONDARY OBJECTIVES: I. To determine the clinical response rate (< cT1) for patients harboring deleterious DDR gene alterations following dose dense gemcitabine and cisplatin. II. To determine the bladder-intact and overall survival for DDR-altered patients with < cT1. III. For DDR gene altered patients who elect radical cystectomy despite < cT1, to determine the pT0 rate in this patient population. IV. To determine the pathologic response rate at cystectomy and 3-year recurrence-free and overall survival for patients without DDR mutations who are registered onto this trial. V. To assess the local treatment burden (Bacillus Calmette-Guerin [BCG] therapy, resection of non-invasive disease, checkpoint blockade) over time in the bladder-sparing group. VI. To determine the bladder-intact disease-free survival in patients who elect to undergo chemoradiation therapy in the DDR mutant group and the DDR wild-type group. OUTLINE: Participants receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on day 1, cisplatin IV on days 1 and 2, and pegfilgrastim subcutaneously (SC) on day 3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Participants are then assigned to 1 of 2 arms. ARM I: Participants with DDR gene alteration and disease stage < cT1 undergo bladder sparing. ARM II: Participants with DDR gene alteration and disease stage >= cT1 or participants without DDR gene alteration undergo radical cystectomy or chemoradiotherapy. After completion of study treatment, participants are followed up for 5 years.


Recruitment information / eligibility

Status Recruiting
Enrollment 271
Est. completion date February 2029
Est. primary completion date February 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Step 1 Patient Registration Eligibility Criteria - Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or examination under anesthesia (EUA). The diagnostic TURBT sample must have been obtained within 60 days prior to registration - 20 unstained slides (10 micron thickness) of formalin-fixed paraffin-embedded (FFPE) pre-treatment diagnostic transurethral resection (TUR) specimen available (for sequencing), with 2 (5 micron) slides at the start and end of the 20 slides, for a total of 22 unstained slides. An FFPE block is also acceptable - Clinical stage T2-T4aN0/xM0 disease - Medically appropriate candidate for radical cystectomy as assessed by surgeon - No concomitant multifocal carcinoma in situ; a single focus is allowed - A single muscle-invasive bladder tumor measuring =5 cm in size as defined by the surgeons at cystoscopic evaluation. When documented, pathologic size at cystoscopy and TURBT will take precedence over radiographic measurements of tumor size. - No clinical or radiographic evidence for locally advanced or metastatic disease - No prior anti-PD-1 or anti PD-L1 therapies, or systemic chemotherapy within the past 5 years (prior intravesical induction immunotherapy for non-muscle invasive disease is allowed, defined as BCG x6 doses and maintenance therapy); BCG refractory disease, defined as disease recurrence within 3 months of BCG therapy, is not allowed. Intravesical chemotherapy is allowed. - No prior radiation therapy to the bladder or prostate - No major surgery or radiation therapy =< 4 weeks of registration (TURBT is allowed). - Not pregnant and not nursing. This study involves an agent that has known genotoxic, mutagenic and teratogenic effects. For women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Absolute neutrophil count (ANC) >= 1,000/mm^3 - Platelet count >= 100,000/mm^3 - Calculated creatinine clearance = 55 mL/min using formula per institutional standard or investigator's discretion. The same formula should be used to calculate all subsequent creatinine clearances. - Total bilirubin =< 1.5 x upper limit of normal (ULN) * (For patients with documented Gilbert's syndrome Total Bilirubin =< 3 x ULN) - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN - Alkaline phosphatase =< 2.5 x ULN - No evidence of New York Heart Association (NYHA) functional class III or IV heart disease - No ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade >= 2 - No pre-existing sensory grade >= 2 neuropathy - No pre-existing grade >= 2 hearing loss - No serious intercurrent medical or psychiatric illness, including serious active infection - None of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack - No known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with the drugs used in this trial. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy, when indicated - No history of allergic reaction attributed to compounds of similar chemical or biologic composition to the agents used in this study - No concurrent treatment on another clinical trial; supportive care trials or non-therapeutic trials (e.g., quality of life) are allowed - No prior malignancy except for: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible - Step 2 Patient Registration Eligibility Criteria - Patients must have completed 4 or more cycles of protocol-directed chemotherapy and DDR gene results must be available - Step 3 Patient Registration Eligibility Criteria (only patients with a DDR gene alteration) - Deleterious alteration within 1 or more of 9 pre-defined DDR genes within the pre-treatment TURBT deoxyribonucleic acid (DNA) - Cystoscopy and imaging performed to determine stage/treatment assignment

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Gemcitabine Hydrochloride
Given IV
Cisplatin
Given IV
Biological:
Pegfilgrastim
Given SC
Procedure:
Conventional Surgery
Undergo bladder sparing
Radical Cystectomy
Undergo radical cystectomy
Other:
Chemoradiotherapy
Undergo chemoradiotherapy

Locations

Country Name City State
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Community Hospital of Anaconda Anaconda Montana
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States Mission Hope Medical Oncology - Arroyo Grande 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 The Medical Center of Aurora Aurora Colorado
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Maryland Proton Treatment Center Baltimore Maryland
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States Flaget Memorial Hospital Bardstown Kentucky
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana
United States LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Our Lady of The Lake Baton Rouge Louisiana
United States Our Lady of the Lake Physician Group Baton Rouge Louisiana
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Billings Clinic Cancer Center Billings Montana
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 Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Essentia Health Saint Joseph's Medical Center Brainerd Minnesota
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States United Hospital Center Bridgeport West Virginia
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Trinity Health Medical Center - Brighton Brighton Michigan
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Roswell Park Cancer Institute Buffalo New York
United States Highline Medical Center-Main Campus Burien Washington
United States Fairview Ridges Hospital Burnsville Minnesota
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Illinois CancerCare-Canton Canton Illinois
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Trinity Health Medical Center - 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 Saint Anthony Regional Hospital Carroll Iowa
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
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 Saint Mary's Hospital Centralia Illinois
United States Medical University of South Carolina Charleston South Carolina
United States Memorial Hospital Chattanooga Tennessee
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States University of Illinois Chicago Illinois
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 Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Cleveland Clinic Foundation Cleveland Ohio
United States Prisma Health Cancer Institute - Laurens Clinton South Carolina
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Mission Cancer and Blood - West Des Moines Clive Iowa
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
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 Central Maryland Radiation Oncology in Howard County Columbia Maryland
United States MU Health - University Hospital/Ellis Fischel Cancer Center Columbia Missouri
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States Mercy Hospital Coon Rapids Minnesota
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Northshore Oncology Associates-Covington Covington Louisiana
United States Greater Regional Medical Center Creston Iowa
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern Simmons Cancer Center - RedBird Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Carle at The Riverfront Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Dayton Physician LLC - Englewood Dayton Ohio
United States Good Samaritan Hospital - Dayton 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 Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes Minnesota
United States Illinois CancerCare-Dixon Dixon Illinois
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 Prisma Health Cancer Institute - Easley Easley South Carolina
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Pocono Medical Center East Stroudsburg Pennsylvania
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Mercy Cancer Center - Elk Grove Elk Grove California
United States Walter Knox Memorial Hospital Emmett Idaho
United States Englewood Hospital and Medical Center Englewood New Jersey
United States Mountain Blue Cancer Care Center - Swedish Englewood Colorado
United States Swedish Medical Center Englewood Colorado
United States The Melanoma and Skin Cancer Institute Englewood Colorado
United States Saint Elizabeth Hospital Enumclaw Washington
United States Illinois CancerCare-Eureka Eureka Illinois
United States Fairbanks Memorial Hospital Fairbanks Alaska
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 Parkland Health Center - Farmington Farmington Missouri
United States Saint Francis Hospital Federal Way Washington
United States Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota
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 Trinity Regional Medical Center Fort Dodge Iowa
United States Holy Cross Hospital Fort Lauderdale Florida
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas
United States Essentia Health - Fosston Fosston Minnesota
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Unity Hospital Fridley Minnesota
United States Gibbs Cancer Center-Gaffney Gaffney South Carolina
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 UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie Maryland
United States Mountain Blue Cancer Care Center Golden Colorado
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Wayne Memorial Hospital Goldsboro North Carolina
United States CTCA at Western Regional Medical Center Goodyear Arizona
United States Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island Nebraska
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Banner North Colorado Medical Center Greeley Colorado
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Prisma Health Greenville Memorial Hospital Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
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 Memorial Sloan Kettering Westchester Harrison New York
United States Hartford Hospital Hartford Connecticut
United States Ingalls Memorial Hospital Harvey Illinois
United States Essentia Health-Hayward Clinic Hayward Wisconsin
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States Pulmonary Medicine Center of Chattanooga-Hixson Hixson Tennessee
United States CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
United States Terrebonne General Medical Center Houma Louisiana
United States Onslow Memorial Hospital Jacksonville North Carolina
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States Essentia Health - Jamestown Clinic Jamestown North Dakota
United States MU Health Care Goldschmidt Cancer Center Jefferson City Missouri
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Kalispell Regional Medical Center Kalispell Montana
United States University of Kansas Cancer Center Kansas City Kansas
United States CHI Health Good Samaritan Kearney Nebraska
United States Heartland Hematology and Oncology Kearney Nebraska
United States First Dayton Cancer Care Kettering Ohio
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 Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Marshfield Medical Center - Ladysmith Ladysmith Wisconsin
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Clare Hospital Lakewood Washington
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Lewistown Hospital Lewistown Pennsylvania
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 Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Littleton Adventist Hospital Littleton Colorado
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Hope Cancer Clinic Livonia Michigan
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Saint Joseph London London Kentucky
United States Sky Ridge Medical Center Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States Rocky Mountain Cancer Centers-Longmont Longmont Colorado
United States Cedars Sinai Medical Center Los Angeles California
United States Jewish Hospital Louisville Kentucky
United States Saints Mary and Elizabeth Hospital Louisville Kentucky
United States UofL Health Medical Center Northeast Louisville Kentucky
United States Banner McKee Medical Center 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 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 Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States WVUH-Berkely Medical Center Martinsburg West Virginia
United States Fremont - Rideout Cancer Center Marysville California
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Aspirus Medford Hospital Medford Wisconsin
United States Mercy Cancer Center Merced California
United States Midstate Medical Center Meriden Connecticut
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States East Jefferson General Hospital Metairie Louisiana
United States LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie Louisiana
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Community Medical Center Missoula Montana
United States Monticello Cancer Center Monticello Minnesota
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States West Virginia University Healthcare Morgantown West Virginia
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States The Hospital of Central Connecticut New Britain Connecticut
United States Louisiana State University Health Science Center New Orleans Louisiana
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States NYP/Weill Cornell Medical Center New York New York
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States HSHS Saint Elizabeth's Hospital O'Fallon Illinois
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
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 Hematology and Oncology Consultants PC Omaha Nebraska
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States Memorial GYN Plus Ooltewah Tennessee
United States Upstate Cancer Center at Oswego Oswego New York
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Midlands Community Hospital Papillion Nebraska
United States Essentia Health - Park Rapids Park Rapids Minnesota
United States Parker Adventist Hospital Parker Colorado
United States Rocky Mountain Cancer Centers-Parker Parker Colorado
United States Camden Clark Medical Center Parkersburg West Virginia
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States Hope Cancer Center Pontiac Michigan
United States Michigan Healthcare Professionals Pontiac Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac Michigan
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Illinois CancerCare-Princeton Princeton Illinois
United States Rhode Island Hospital Providence Rhode Island
United States Rocky Mountain Cancer Centers - Pueblo Pueblo Colorado
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Ascension Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States UT Southwestern Clinical Center at Richardson/Plano Richardson Texas
United States Reid Health Richmond Indiana
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States University of Rochester Rochester New York
United States Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan
United States Mercy Cancer Center - Rocklin Rocklin California
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Mercy Cancer Center - Sacramento Sacramento California
United States University of California Davis Comprehensive 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 Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota
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 Siteman Cancer Center at Christian Hospital Saint Louis Missouri
United States Siteman Cancer Center-South County Saint Louis Missouri
United States Washington University School of Medicine 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 Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Essentia Health Sandstone Sandstone Minnesota
United States Mission Hope Medical Oncology - Santa Maria Santa Maria California
United States Community Medical Center Scranton Pennsylvania
United States Geisinger Medical Oncology-Selinsgrove Selinsgrove Pennsylvania
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Jewish Hospital Medical Center South Shepherdsville Kentucky
United States Welch Cancer Center Sheridan Wyoming
United States Saint Michael Cancer Center Silverdale Washington
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 Spartanburg Medical Center Spartanburg South Carolina
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 Mercy Medical Center Springfield Massachusetts
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 Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States BJC Outpatient Center at Sunset Hills Sunset Hills Missouri
United States Essentia Health Saint Mary's Hospital - Superior Superior Wisconsin
United States Southwest Illinois Health Services LLP Swansea Illinois
United States State University of New York Upstate Medical University Syracuse New York
United States Franciscan Research Center-Northwest Medical Plaza Tacoma Washington
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Sanford Thief River Falls Medical Center Thief River Falls Minnesota
United States Rocky Mountain Cancer Centers-Thornton Thornton Colorado
United States Dayton Physicians LLC - Troy Troy Ohio
United States Upper Valley Medical Center Troy Ohio
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States MGC Hematology Oncology-Union Union South Carolina
United States Memorial Sloan Kettering Nassau Uniondale New York
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Upstate Cancer Center at Verona Verona New York
United States Essentia Health Virginia Clinic Virginia Minnesota
United States Ridgeview Medical Center Waconia Minnesota
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 Aspirus Regional Cancer Center Wausau Wisconsin
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Methodist West Hospital West Des Moines Iowa
United States Diagnostic and Treatment Center Weston Wisconsin
United States Marshfield Medical Center - Weston Weston Wisconsin
United States University of Kansas Hospital-Westwood Cancer Center Westwood Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
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 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

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients who are recurrence-free within the DDR mutated group who undergo the bladder sparing approach Will use Kaplan Meier survival analysis to estimate the proportion of patients who are recurrence-free at three years. Will use a one-sided 90% confidence interval. At 3 years
Secondary Clinical response rate for patients harboring deleterious DDR gene alterations Will be defined as the number of patients with less than a cT1 response divided by the total number of patients harboring deleterious DDR gene alterations who completed 6 cycles of dose dense gemcitabine and cisplatin. After 6 courses (84 days)
Secondary Bladder-intact survival in DDR-altered patients with < cT1 responses who selected the bladder sparing approach Will be estimated with Kaplan-Meier estimators and corresponding 95% confidence intervals. Time from registration up to 5 years
Secondary Overall survival Will be estimated with Kaplan-Meier estimators and corresponding 95% confidence intervals. Time from study registration up to 5 years
Secondary Pathologic response (pT0) rate at cystectomy in participants without DDR gene alterations This will be the number of patients without DDR gene alterations with pT0 at cystectomy divided by the number of patients without DDR gene alterations who underwent cystectomy following the completion of dose dense gemcitabine and cisplatin treatment. Will be estimated with a binomial point estimate and corresponding 95% binomial confidence intervals. Up to 5 years
Secondary Recurrence-free survival The Kaplan-Meier estimator will be used to estimate the proportion of patients who are recurrence-free success at three years under the two alternative definitions of recurrence-free success above. The point estimate for the three-year recurrence free survival rate will be reported with a 95% confidence interval. These analyses will also be repeated for 5-year recurrence free survival. Time from study registration up to 5 years
Secondary The rate of cystectomies in patients with a DDR alteration and with a cT0/CIS/Ta response Will be computed as the number of patients with a DDR alteration and with a cT0/CIS/Ta response who undergo a cystectomy within 3 years divided by the total number of patients with a DDR alteration and with a cT0/CIS/Ta response. Will be estimated with a binomial point estimate and corresponding 95% binomial confidence intervals. Within 3 years
Secondary Proportion of patients in the bladder-sparing group who undergo local therapy Will be estimated with a binomial point estimate and 95% binomial confidence interval. The estimate will be determined as the number of patients who undergo local treatment (BCG or resection of non-invasive disease) in the bladder-sparing group divided by the total number of patients in the bladder-sparing group. Up to 5 years
See also
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