Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations
Infiltrating Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Stage III Bladder Urothelial Carcinoma
About this trial
This is an interventional treatment trial for Infiltrating Bladder Urothelial Carcinoma
Eligibility Criteria
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
Sites / Locations
- Fairbanks Memorial HospitalRecruiting
- CTCA at Western Regional Medical Center
- Cancer Center at Saint Joseph'sRecruiting
- Mercy Hospital Fort SmithRecruiting
- CHI Saint Vincent Cancer Center Hot Springs
- University of Arkansas for Medical SciencesRecruiting
- Mission Hope Medical Oncology - Arroyo GrandeRecruiting
- Mercy Cancer Center �� CarmichaelRecruiting
- Mercy San Juan Medical CenterRecruiting
- Mercy Cancer Center - Elk GroveRecruiting
- Cedars Sinai Medical Center
- Fremont - Rideout Cancer CenterRecruiting
- Mercy Cancer Center - RocklinRecruiting
- Mercy Cancer Center - SacramentoRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- Pacific Central Coast Health Center-San Luis ObispoRecruiting
- Mission Hope Medical Oncology - Santa MariaRecruiting
- Woodland Memorial HospitalRecruiting
- Rocky Mountain Cancer Centers-AuroraRecruiting
- The Medical Center of Aurora
- Rocky Mountain Cancer Centers-BoulderRecruiting
- Penrose-Saint Francis HealthcareRecruiting
- Rocky Mountain Cancer Centers-PenroseRecruiting
- Saint Francis Cancer CenterRecruiting
- Porter Adventist HospitalRecruiting
- Presbyterian - Saint Lukes Medical Center - Health OneRecruiting
- Mercy Medical Center
- Southwest Oncology PC
- Mountain Blue Cancer Care Center - SwedishRecruiting
- Swedish Medical CenterRecruiting
- The Melanoma and Skin Cancer InstituteRecruiting
- Mountain Blue Cancer Care Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony HospitalRecruiting
- Rocky Mountain Cancer Centers-LittletonRecruiting
- Littleton Adventist HospitalRecruiting
- Sky Ridge Medical Center
- Longmont United HospitalRecruiting
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist HospitalRecruiting
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical CenterRecruiting
- Rocky Mountain Cancer Centers - Pueblo
- Rocky Mountain Cancer Centers-ThorntonRecruiting
- Hartford HospitalRecruiting
- Midstate Medical CenterRecruiting
- The Hospital of Central ConnecticutRecruiting
- Holy Cross HospitalRecruiting
- University of Florida Health Science Center - GainesvilleRecruiting
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Health - Coeur d'AleneRecruiting
- Walter Knox Memorial Hospital
- Idaho Urologic Institute-MeridianRecruiting
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Kootenai Clinic Cancer Services - Post FallsRecruiting
- Kootenai Cancer Clinic
- Rush - Copley Medical CenterRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Memorial Hospital of CarbondaleRecruiting
- SIH Cancer InstituteRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- Saint Mary's HospitalRecruiting
- University of Illinois
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Illinois CancerCare-DixonRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- Ingalls Memorial HospitalRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Good Samaritan Regional Health CenterRecruiting
- Cancer Care Center of O'FallonRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Illinois CancerCare-PekinRecruiting
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment CenterRecruiting
- Illinois CancerCare-PeoriaRecruiting
- OSF Saint Francis Radiation Oncology at Peoria Cancer CenterRecruiting
- Methodist Medical Center of IllinoisRecruiting
- OSF Saint Francis Medical CenterRecruiting
- Illinois CancerCare-PeruRecruiting
- Valley Radiation OncologyRecruiting
- Illinois CancerCare-PrincetonRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Southwest Illinois Health Services LLP
- Carle Cancer CenterRecruiting
- The Carle Foundation HospitalRecruiting
- Illinois CancerCare - WashingtonRecruiting
- Reid HealthRecruiting
- Saint Anthony Regional Hospital
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- Trinity Regional Medical Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Central Care Cancer Center - Garden CityRecruiting
- Central Care Cancer Center - Great BendRecruiting
- University of Kansas Cancer Center
- University of Kansas Hospital-Westwood Cancer Center
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Saint Joseph HospitalRecruiting
- Saint Joseph Radiation Oncology Resource CenterRecruiting
- Saint Joseph Hospital EastRecruiting
- Saint Joseph London
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Jewish Hospital Medical Center South
- LSU Health Baton Rouge-North ClinicRecruiting
- Our Lady of The LakeRecruiting
- Louisiana Hematology Oncology Associates LLCRecruiting
- Mary Bird Perkins Cancer CenterRecruiting
- Our Lady of the Lake Physicians Group - Medical OncologyRecruiting
- Northshore Oncology Associates-CovingtonRecruiting
- Terrebonne General Medical CenterRecruiting
- East Jefferson General HospitalRecruiting
- LSU Healthcare Network / Metairie Multi-Specialty ClinicRecruiting
- Louisiana State University Health Science CenterRecruiting
- University Medical Center New Orleans
- Ochsner Medical Center Jefferson
- Maryland Proton Treatment Center
- University of Maryland/Greenebaum Cancer Center
- Central Maryland Radiation Oncology in Howard County
- UM Baltimore Washington Medical Center/Tate Cancer Center
- Mercy Medical Center
- Saint Joseph Mercy HospitalRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Caro Cancer CenterRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- Hematology Oncology Consultants-Clarkston
- Newland Medical Associates-Clarkston
- Ascension Saint John HospitalRecruiting
- Great Lakes Cancer Management Specialists-Doctors Park
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer InstituteRecruiting
- Hurley Medical CenterRecruiting
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer CenterRecruiting
- Michigan Breast Specialists-Grosse Pointe Woods
- Sparrow HospitalRecruiting
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of MarletteRecruiting
- 21st Century Oncology-PontiacRecruiting
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy OaklandRecruiting
- Great Lakes Cancer Management Specialists-Rochester Hills
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Bhadresh Nayak MD PC-Sterling Heights
- Ascension Saint Joseph HospitalRecruiting
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- Huron Gastroenterology PC
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Essentia Health Saint Joseph's Medical CenterRecruiting
- Fairview Ridges Hospital
- Minnesota Oncology - BurnsvilleRecruiting
- Mercy HospitalRecruiting
- Essentia Health - Deer River ClinicRecruiting
- Essentia Health Saint Mary's - Detroit Lakes ClinicRecruiting
- Essentia Health Cancer CenterRecruiting
- Essentia Health Saint Mary's Medical CenterRecruiting
- Miller-Dwan HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Lake Region Healthcare Corporation-Cancer Care
- Essentia Health - FosstonRecruiting
- Unity HospitalRecruiting
- Essentia Health Hibbing ClinicRecruiting
- Fairview Clinics and Surgery Center Maple GroveRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Saint John's Hospital - HealtheastRecruiting
- Abbott-Northwestern HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Health Partners IncRecruiting
- Monticello Cancer CenterRecruiting
- New Ulm Medical Center
- Essentia Health - Park RapidsRecruiting
- North Memorial Medical Health CenterRecruiting
- Coborn Cancer Center at Saint Cloud HospitalRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Essentia Health SandstoneRecruiting
- Saint Francis Regional Medical CenterRecruiting
- Lakeview HospitalRecruiting
- Sanford Thief River Falls Medical Center
- Essentia Health Virginia ClinicRecruiting
- Ridgeview Medical CenterRecruiting
- Rice Memorial HospitalRecruiting
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Sanford Cancer Center Worthington
- Fairview Lakes Medical Center
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - BolivarRecruiting
- Parkland Health Center-Bonne Terre
- Saint Francis Medical CenterRecruiting
- Southeast Cancer CenterRecruiting
- MU Health - University Hospital/Ellis Fischel Cancer CenterRecruiting
- Siteman Cancer Center at West County HospitalRecruiting
- Parkland Health Center - FarmingtonRecruiting
- Capital Region Southwest CampusRecruiting
- Freeman Health SystemRecruiting
- Mercy Hospital JoplinRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Heartland Regional Medical CenterRecruiting
- Washington University School of MedicineRecruiting
- Mercy Hospital SouthRecruiting
- Siteman Cancer Center-South CountyRecruiting
- Missouri Baptist Medical CenterRecruiting
- Siteman Cancer Center at Christian HospitalRecruiting
- Mercy Hospital Saint LouisRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Community Hospital of Anaconda
- Billings Clinic Cancer CenterRecruiting
- Bozeman Deaconess HospitalRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Great Falls ClinicRecruiting
- Saint Peter's Community Hospital
- Kalispell Regional Medical CenterRecruiting
- Community Medical HospitalRecruiting
- CHI Health Saint Francis
- Heartland Hematology and Oncology
- CHI Health Good SamaritanRecruiting
- Saint Elizabeth Regional Medical Center
- Alegent Health Immanuel Medical CenterRecruiting
- Hematology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical CenterRecruiting
- Alegent Health Lakeside HospitalRecruiting
- Creighton University Medical CenterRecruiting
- Midlands Community Hospital
- Memorial Sloan Kettering Basking RidgeRecruiting
- Englewood Hospital and Medical CenterRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Roswell Park Cancer Institute
- Memorial Sloan Kettering CommackRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- NYP/Weill Cornell Medical CenterRecruiting
- Upstate Cancer Center at OneidaRecruiting
- Upstate Cancer Center at OswegoRecruiting
- State University of New York Upstate Medical UniversityRecruiting
- Memorial Sloan Kettering NassauRecruiting
- Southeastern Medical Oncology Center-Clinton
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Onslow Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Sanford Bismarck Medical CenterRecruiting
- Essentia Health Cancer Center-South University ClinicRecruiting
- Sanford South University Medical Center
- Sanford Medical Center Fargo
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Essentia Health - Jamestown ClinicRecruiting
- Indu and Raj Soin Medical CenterRecruiting
- Saint Elizabeth Boardman HospitalRecruiting
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Miami Valley Hospital South
- Good Samaritan Hospital - CincinnatiRecruiting
- Oncology Hematology Care Inc-KenwoodRecruiting
- Bethesda North HospitalRecruiting
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Cleveland Clinic FoundationRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital North
- Armes Family Cancer CenterRecruiting
- Blanchard Valley HospitalRecruiting
- Orion Cancer CareRecruiting
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-AtriumRecruiting
- Dayton Physicians LLC-WayneRecruiting
- Wayne HospitalRecruiting
- Greater Dayton Cancer CenterRecruiting
- First Dayton Cancer Care
- Kettering Medical CenterRecruiting
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- Dayton Physicians LLC - TroyRecruiting
- Upper Valley Medical Center
- Saint Joseph Warren HospitalRecruiting
- Saint Elizabeth Youngstown HospitalRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Alphonsus Medical Center-Baker City
- Saint Alphonsus Medical Center-Ontario
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Geisinger Medical CenterRecruiting
- Pocono Medical CenterRecruiting
- Geisinger Medical Center-Cancer Center HazletonRecruiting
- Lehigh Valley Hospital-Hazleton
- Geisinger Medical Oncology-LewisburgRecruiting
- Lewistown HospitalRecruiting
- Geisinger Cancer Services-PottsvilleRecruiting
- Community Medical CenterRecruiting
- Geisinger Medical Oncology-SelinsgroveRecruiting
- Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
- Rhode Island HospitalRecruiting
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South Carolina
- Prisma Health Cancer Institute - Laurens
- Prisma Health Cancer Institute - Easley
- Gibbs Cancer Center-GaffneyRecruiting
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Gibbs Cancer Center-PelhamRecruiting
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical CenterRecruiting
- MGC Hematology Oncology-UnionRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Memorial Hospital
- Pulmonary Medicine Center of Chattanooga-Hixson
- Memorial GYN Plus
- Saint Joseph Regional Cancer Center
- Parkland Memorial HospitalRecruiting
- UT Southwestern Simmons Cancer Center - RedBirdRecruiting
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- UT Southwestern/Simmons Cancer Center-Fort WorthRecruiting
- UT Southwestern Clinical Center at Richardson/PlanoRecruiting
- Harrison HealthPartners Hematology and Oncology-BremertonRecruiting
- Harrison Medical CenterRecruiting
- Highline Medical Center-Main Campus
- Saint Elizabeth Hospital
- Saint Francis Hospital
- Saint Clare Hospital
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Franciscan Research Center-Northwest Medical Plaza
- Northwest Medical Specialties PLLC
- United Hospital Center
- WVUH-Berkely Medical Center
- West Virginia University Healthcare
- Camden Clark Medical Center
- Langlade Hospital and Cancer CenterRecruiting
- Duluth Clinic AshlandRecruiting
- Northwest Wisconsin Cancer CenterRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Essentia Health-Hayward ClinicRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- Marshfield Clinic - Ladysmith CenterRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Aspirus Medford HospitalRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Essentia Health-Spooner ClinicRecruiting
- Ascension Saint Michael's HospitalRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- Essentia Health Saint Mary's Hospital - SuperiorRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Diagnostic and Treatment CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
- Billings Clinic-Cody
- Welch Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (gemcitabine, cisplatin, bladder sparing)
Arm II (gemcitabine, cisplatin, cystectomy, chemoradiotherapy)
Participants receive gemcitabine hydrochloride IV over 30 minutes on day 1, cisplatin IV on days 1 and 2, and pegfilgrastim SC on day 3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Participants with DDR gene alteration and disease stage < cT1 undergo bladder sparing.
Participants receive gemcitabine hydrochloride IV over 30 minutes on day 1, cisplatin IV on days 1 and 2, and pegfilgrastim SC on day 3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Participants with DDR gene alteration and disease stage >= cT1 or participants without DDR gene alteration undergo radical cystectomy or chemoradiotherapy.