Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer
Bladder Urothelial Carcinoma, Muscle Invasive Bladder Carcinoma, Stage II Bladder Cancer AJCC v8
About this trial
This is an interventional treatment trial for Bladder Urothelial Carcinoma
Eligibility Criteria
Inclusion Criteria:
- STEP 1 REGISTRATION: If this will be the first patient from a registering site to receive a given RT modality (3DCRT vs. IMRT), the site must first submit pre-RT planning documents within 3 days of Step 1 registration and receive approval from Imaging and Radiation Oncology Core (IROC) before randomizing the patient to Step 2. If this will not be the first patient to receive a specific RT modality, the patient should be immediately randomized to Step 2 on the same day.
- STEP 2 RANDOMIZATION: If patient required review of pre-RT planning, randomization must occur within 14 days of initial registration.
- Patients must have histologically proven, T2-T4a N0M0 urothelial carcinoma of the bladder within 120 days prior to randomization and no intervening treatment between the histologic proof and randomization. Patients with mixed urothelial carcinoma will be eligible for the trial, but the presence of small cell carcinoma will make a patient ineligible. Patients with lymph nodes >= 1.0 cm in shortest cross-sectional diameter on imaging (computed tomography [CT]/magnetic resonance imaging [MRI] of abdomen and pelvis) must have a biopsy of the enlarged lymph node showing no tumor involvement within 70 days prior to randomization. These patients may be suitable for neoadjuvant chemotherapy and radical cystectomy and are eligible for this trial if they seek out a bladder sparing treatment strategy, however patients who have received prior systemic chemotherapy for bladder cancer are not eligible for the trial.
- Patients must undergo a transurethral resection of bladder tumor (TURBT) within 70 days prior to randomization. In a situation where a patient is referred from outside to the enrolling institution, patient must have a repeat office cystoscopy by the urologist who will be following the patient on the clinical trial to assess the adequacy of the prior TURBT. This cystoscopy can be performed in urologist office without general anesthesia. Patient may then undergo repeat TURBT if deemed necessary as standard of care by the treating urologist. Patients may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection. Patient must not have T4b disease
- Patients must undergo radiological staging within 70 days prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Patients must not have evidence of T4bN1-3 disease. Eligibility is based on the local radiology report.
- Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meets criteria specified.
- Patient must be planning to receive one of the protocol specified chemotherapy regimens.
- All adverse events associated with any prior surgery and intravesical therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade =< 2 prior to randomization.
- Patients must be >= 18 years of age
- Patient may or may not be radical cystectomy candidates.
- Absolute neutrophil count (ANC) >=1,500/microliter (mcL) (within 28 days prior to randomization).
- Platelets >= 100,000/mcL (within 28 days prior to randomization).
- Hemoglobin >= 9 g/dL (within 28 days prior to randomization).
- Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except patients with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL) (within 28 days prior to randomization).
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x IULN (within 28 days prior to randomization).
- Patients must have adequate renal function as evidenced by calculated creatinine clearance >= 25 mL/min. The creatinine used to calculate the clearance result must have been obtained within 28 days prior to randomization.
- Patients must have Zubrod performance status =< 2.
- Patients must have a baseline electrocardiography (ECG) performed within 30 days prior to randomization.
If patient has a known history of hepatitis B virus (HBV) or hepatitis C virus (HCV), they must meet the following criteria within 28 days prior to randomization.
- Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible.
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
Patients who are known to be positive for human immunodeficiency virus (HIV) are eligible only if they have all of the following:
- A stable regimen of highly active anti-retroviral therapy (HAART)
- No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
- A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests within 28 days prior to randomization.
- Female patients of childbearing potential must have a serum pregnancy test prior to randomization. Patients must not be pregnant or nursing due to the potential teratogenic side effects of the protocol treatment. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of protocol treatment, and for 5 months (150 days) after the last dose of all study drugs. A woman is considered to be of "reproductive potential" if she has had a menses at any time in the preceding 12 consecutive months.
- Patients must be offered the opportunity to participate in specimen banking for future studies.
- Patients who can complete Patient-Reported Outcome instruments in English or Spanish must agree to complete the EORTC QLQ-C30, the EORTC QLQ-BLM30, the EPIC Bowel Assessment, and the EQ-5D-5L per protocol schedule of assessment.
- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
Exclusion Criteria:
- Patients must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within the previous 24 months except Ta/T1/carcinoma in situ (CIS) of the upper urinary tract including renal pelvis and ureter if the patient had undergone complete nephroureterectomy.
- Patients must not have diffuse CIS based on cystoscopy and biopsy.
- Patient must not have received any systemic chemotherapy for their bladder cancer.
- Patient must not have had prior pelvic radiation.
- Patients must not have received prior treatment for muscle invasive bladder cancer including neoadjuvant chemotherapy for the current tumor.
- Patients must not have received any systemic therapy (including, but not limited to, interferon alfa-2b, high dose IL-2, pegylated interferon [PEG-IFN], anti-PD-1, anti-PD-L1), for non-muscle invasive bladder cancer. Prior intravesical bacillus Calmette-Guerin (BCG), interferon, and intravesical chemotherapy are allowed.
Patients must not have received any of the following prohibited therapies within 28 days prior to randomization or be planning to receive any of the following prohibited therapies during protocol treatment:
- Anti-cancer systemic chemotherapy or biological therapy not specified in the protocol.
- Immunotherapy not specified in this protocol.
- Systemic or intravesical use of any non-study anti-cancer agent (investigational or non-investigational).
- Investigational agents other than atezolizumab.
- Live vaccines: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and are not allowed. Prior administration of intravesical BCG is allowed.
- Glucocorticoids for any purpose other than to modulate symptoms from an event of suspected immunologic etiology. The use of physiologic doses of corticosteroids (defined as 10 mg prednisone) are acceptable, however site investigators should consult with the study chair for any dose higher than 10 mg prednisone. Dexamethasone 4 mg IV with chemotherapy to prevent nausea is allowed.
- RANKL infusion: Concurrent denosumab (which binds the cytokine RANKL) for any known indication is prohibited due to interaction with study medication.
- Patients must not have a major surgical procedure within 28 days prior to randomization. If patient had any surgical procedure then they should have recovered to full presurgical performance status and surgical adverse events should have resolved to grade =< 2. TURBT is not considered a major surgical procedure.
Patients must not have received treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14 days prior to randomization. Exceptions:
- Patients may have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea).
- The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed. Physiological doses equivalent of 10 mg prednisone daily are allowed. Short term steroids given as antiemetic therapy, e.g. 4 mg dexamethasone or equivalent once a week, is allowed.
Patients must not have received a live, attenuated vaccine within 4 weeks prior to randomization or anticipate that such a live, attenuated vaccine will be required while on protocol treatment and up to 5 months after the last dose of protocol treatment.
- Inactivated influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine within 4 weeks prior to randomization or while on protocol treatment and up to 5 months after the last dose of protocol treatment.
- Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- Patients must not have clinically significant liver disease that precludes patient from treatment regimens prescribed on the study (including, but not limited to, active viral, alcoholic or other autoimmune hepatitis, cirrhosis or inherited liver disease).
- Patient must not have history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis.
- Patients must not have an active infection requiring oral or IV antibiotics within 14 days prior to randomization. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are not eligible. If patient develops urinary tract infection after TURBT they must have recovered from the infection prior to registration.
- Patients must not have active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Autoimmune diseases include, but are not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, Graves' disease treated with methimazole or glomerulonephritis.
- Patient must not have a history of active tuberculosis.
- No other prior malignancy is allowed except for the following: adequately treated basal cell 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 two years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.
- Patients must not be known to be allergic to Chinese hamster egg or ovary cell products and must not have any known major allergic reactions to any study drug.
Sites / Locations
- Mayo Clinic Hospital in ArizonaRecruiting
- Mayo Clinic in ArizonaRecruiting
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- Sutter Auburn Faith HospitalRecruiting
- Sutter Cancer Centers Radiation Oncology Services-AuburnRecruiting
- Alta Bates Summit Medical Center-Herrick CampusRecruiting
- Mercy Cancer Center �� CarmichaelRecruiting
- Mercy San Juan Medical CenterRecruiting
- Mercy Cancer Center - Elk GroveRecruiting
- UC San Diego Moores Cancer CenterRecruiting
- Los Angeles County-USC Medical CenterRecruiting
- USC / Norris Comprehensive Cancer CenterRecruiting
- Cedars Sinai Medical CenterRecruiting
- Fremont - Rideout Cancer CenterRecruiting
- Memorial Medical CenterRecruiting
- UC Irvine Health/Chao Family Comprehensive Cancer CenterRecruiting
- Palo Alto Medical Foundation Health CareRecruiting
- Mercy Cancer Center - RocklinRecruiting
- Sutter Roseville Medical CenterRecruiting
- Mercy Cancer Center - SacramentoRecruiting
- Sutter Medical Center SacramentoRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- Pacific Central Coast Health Center-San Luis ObispoRecruiting
- Palo Alto Medical Foundation-SunnyvaleRecruiting
- Woodland Memorial HospitalRecruiting
- UCHealth University of Colorado HospitalRecruiting
- Rocky Mountain Cancer Centers-BoulderRecruiting
- UCHealth Memorial Hospital CentralRecruiting
- Memorial Hospital NorthRecruiting
- Shaw Cancer CenterRecruiting
- Poudre Valley HospitalRecruiting
- Cancer Care and Hematology-Fort CollinsRecruiting
- North Colorado Medical Center
- UCHealth Greeley HospitalRecruiting
- Medical Center of the RockiesRecruiting
- McKee Medical Center
- Smilow Cancer Hospital Care Center - GuilfordRecruiting
- Hartford HospitalRecruiting
- Midstate Medical Center
- The Hospital of Central Connecticut
- Yale UniversityRecruiting
- Smilow Cancer Hospital Care Center-TrumbullRecruiting
- Beebe South Coastal Health CampusRecruiting
- Helen F Graham Cancer CenterRecruiting
- Medical Oncology Hematology Consultants PARecruiting
- Beebe Health CampusRecruiting
- Sibley Memorial HospitalRecruiting
- Mount Sinai Comprehensive Cancer Center at Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
- University of Florida Health Science Center - Gainesville
- Mount Sinai Medical CenterRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Florida Cancer Specialists - SarasotaRecruiting
- Florida Cancer Specialists - Sarasota DowntownRecruiting
- Sarasota Memorial HospitalRecruiting
- Sarasota Memorial Health Care Center at University ParkwayRecruiting
- Moffitt Cancer Center
- Emory University Hospital MidtownRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Emory Saint Joseph's HospitalRecruiting
- CTCA at Southeastern Regional Medical Center
- Hawaii Cancer Care - WestridgeRecruiting
- Pali Momi Medical CenterRecruiting
- The Cancer Center of Hawaii-Pali MomiRecruiting
- Hawaii Cancer Care Inc - Waterfront PlazaRecruiting
- Queen's Cancer Cenrer - POB IRecruiting
- Queen's Medical CenterRecruiting
- Straub Clinic and HospitalRecruiting
- Queen's Cancer Center - KuakiniRecruiting
- The Cancer Center of Hawaii-LilihaRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Illinois CancerCare-CarthageRecruiting
- Northwestern UniversityRecruiting
- Rush University Medical CenterRecruiting
- Advocate Illinois Masonic Medical CenterRecruiting
- Decatur Memorial HospitalRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Crossroads Cancer CenterRecruiting
- Elmhurst Memorial HospitalRecruiting
- Illinois CancerCare-EurekaRecruiting
- NorthShore University HealthSystem-Evanston HospitalRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- NorthShore University HealthSystem-Glenbrook HospitalRecruiting
- NorthShore University HealthSystem-Highland Park HospitalRecruiting
- Edward Hines Jr VA HospitalRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Condell Memorial HospitalRecruiting
- Illinois CancerCare-MacombRecruiting
- Loyola University Medical CenterRecruiting
- Edward Hospital/Cancer CenterRecruiting
- Advocate Christ Medical CenterRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Advocate Lutheran General HospitalRecruiting
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- Methodist Medical Center of IllinoisRecruiting
- OSF Saint Francis Medical CenterRecruiting
- Illinois CancerCare-PeruRecruiting
- Illinois CancerCare-PrincetonRecruiting
- Springfield Clinic
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Illinois CancerCare - WashingtonRecruiting
- Community Cancer Center East
- Community Cancer Center South
- Community Cancer Center North
- Reid HealthRecruiting
- Mary Greeley Medical Center
- McFarland Clinic - AmesRecruiting
- Medical Oncology and Hematology Associates-West Des MoinesRecruiting
- Mercy Cancer Center-West LakesRecruiting
- Greater Regional Medical CenterRecruiting
- Iowa Methodist Medical Center
- Mercy Medical Center - Des MoinesRecruiting
- Mission Cancer and Blood - LaurelRecruiting
- Mercy Medical Center-West LakesRecruiting
- University of Kansas Cancer CenterRecruiting
- University of Kansas Cancer Center-Overland ParkRecruiting
- University of Kansas Hospital-Westwood Cancer CenterRecruiting
- Ascension Via Christi Hospitals WichitaRecruiting
- Baptist Health LexingtonRecruiting
- University of Kentucky/Markey Cancer Center
- The James Graham Brown Cancer Center at University of Louisville
- Baptist Health LouisvilleRecruiting
- Louisiana Hematology Oncology Associates LLCRecruiting
- Mary Bird Perkins Cancer CenterRecruiting
- East Jefferson General HospitalRecruiting
- LSU Healthcare Network / Metairie Multi-Specialty ClinicRecruiting
- University Medical Center New OrleansRecruiting
- MaineHealth Coastal Cancer Treatment CenterRecruiting
- Waldo County General Hospital
- MaineHealth/SMHC Cancer Care and Blood Disorders-BiddefordRecruiting
- Stephens Memorial Hospital
- Maine Medical Center-Bramhall CampusRecruiting
- Penobscot Bay Medical Center
- MaineHealth Cancer Care Center of York CountyRecruiting
- MaineHealth/SMHC Cancer Care and Blood Disorders-SanfordRecruiting
- Maine Medical Center- Scarborough CampusRecruiting
- Maine Medical Partners - South PortlandRecruiting
- Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
- Massachusetts General Hospital Cancer CenterRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Lowell General Hospital
- Saint Joseph Mercy HospitalRecruiting
- University of Michigan Comprehensive Cancer CenterRecruiting
- Bronson Battle CreekRecruiting
- Saint Joseph Mercy BrightonRecruiting
- University of Michigan - Brighton Center for Specialty Care
- Saint Joseph Mercy CantonRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Michigan Healthcare Professionals ClarkstonRecruiting
- Beaumont Hospital - DearbornRecruiting
- Wayne State University/Karmanos Cancer Institute
- Henry Ford HospitalRecruiting
- Ascension Saint John HospitalRecruiting
- Michigan Healthcare Professionals FarmingtonRecruiting
- Weisberg Cancer Treatment Center
- Beaumont Hospital - Farmington HillsRecruiting
- West Michigan Cancer CenterRecruiting
- Sparrow HospitalRecruiting
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
- Michigan Healthcare Professionals Madison HeightsRecruiting
- 21st Century Oncology-Pontiac
- William Beaumont Hospital-Royal OakRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Munson Medical CenterRecruiting
- William Beaumont Hospital - TroyRecruiting
- GenesisCare USA - TroyRecruiting
- Saint John Macomb-Oakland HospitalRecruiting
- Henry Ford West Bloomfield HospitalRecruiting
- University of Michigan Health - WestRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Mercy HospitalRecruiting
- Miller-Dwan HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Unity Hospital
- Monticello Cancer CenterRecruiting
- Mayo Clinic in Rochester
- Coborn Cancer Center at Saint Cloud HospitalRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- Parkland Health Center-Bonne Terre
- Saint Francis Medical CenterRecruiting
- Siteman Cancer Center at West County HospitalRecruiting
- University of Kansas Cancer Center - NorthRecruiting
- University of Kansas Cancer Center - Lee's SummitRecruiting
- Heartland Regional Medical CenterRecruiting
- Washington University School of MedicineRecruiting
- Mercy Hospital SouthRecruiting
- Siteman Cancer Center-South CountyRecruiting
- Missouri Baptist Medical CenterRecruiting
- Mercy Hospital Saint LouisRecruiting
- Siteman Cancer Center at Saint Peters HospitalRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- CoxHealth South HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Billings Clinic Cancer CenterRecruiting
- Bozeman Deaconess HospitalRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Nebraska Medicine-Bellevue
- CHI Health Good SamaritanRecruiting
- Nebraska Methodist HospitalRecruiting
- Nebraska Medicine-Village Pointe
- University of Nebraska Medical Center
- OptumCare Cancer Care at CharlestonRecruiting
- Radiation Oncology Centers of Nevada CentralRecruiting
- Radiation Oncology Centers of Nevada SoutheastRecruiting
- Comprehensive Cancer Centers of Nevada - NorthwestRecruiting
- Comprehensive Cancer Centers of Nevada - Town CenterRecruiting
- Comprehensive Cancer Centers of NevadaRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting
- Renown Regional Medical CenterRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Cooper Hospital University Medical Center
- Hackensack University Medical CenterRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- MD Anderson Cancer Center at Cooper-Voorhees
- Montefiore Medical Center-Einstein CampusRecruiting
- Montefiore Medical Center-Weiler HospitalRecruiting
- Montefiore Medical Center - Moses CampusRecruiting
- Memorial Sloan Kettering CommackRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- Northwell Health/Center for Advanced MedicineRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Highland HospitalRecruiting
- University of RochesterRecruiting
- Phelps Memorial Hospital Center
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- Memorial Sloan Kettering NassauRecruiting
- Good Samaritan Hospital Medical CenterRecruiting
- Margaret R Pardee Memorial HospitalRecruiting
- Vidant Oncology-KenansvilleRecruiting
- Vidant Oncology-KinstonRecruiting
- Vidant Oncology-Richlands
- Sanford Bismarck Medical CenterRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- University of Cincinnati Cancer Center-UC Medical Center
- MetroHealth Medical CenterRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Greater Dayton Cancer CenterRecruiting
- Kettering Medical CenterRecruiting
- University of Cincinnati Cancer Center-West Chester
- Cancer Centers of Southwest Oklahoma ResearchRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Oregon Health and Science UniversityRecruiting
- Lehigh Valley Hospital-Cedar CrestRecruiting
- UPMC AltoonaRecruiting
- UPMC-Heritage Valley Health System BeaverRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Carlisle Regional Cancer CenterRecruiting
- Christiana Care Health System-Concord Health CenterRecruiting
- Geisinger Medical CenterRecruiting
- UPMC Hillman Cancer Center ErieRecruiting
- UPMC Cancer Center at UPMC HorizonRecruiting
- UPMC Cancer Centers - Arnold Palmer PavilionRecruiting
- UPMC Pinnacle Cancer Center/Community Osteopathic CampusRecruiting
- Penn State Milton S Hershey Medical CenterRecruiting
- UPMC-Johnstown/John P. Murtha Regional Cancer CenterRecruiting
- Geisinger Medical Oncology-LewisburgRecruiting
- UPMC Cancer Center at UPMC McKeesport
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionRecruiting
- UPMC Cancer Center - MonroevilleRecruiting
- UPMC Hillman Cancer Center in CoraopolisRecruiting
- Arnold Palmer Cancer Center Medical Oncology NorwinRecruiting
- UPMC Hillman Cancer Center - New CastleRecruiting
- UPMC-Magee Womens HospitalRecruiting
- UPMC-Saint MargaretRecruiting
- University of Pittsburgh Cancer Institute (UPCI)Recruiting
- UPMC-Shadyside HospitalRecruiting
- UPMC-Passavant HospitalRecruiting
- UPMC-Saint Clair Hospital Cancer CenterRecruiting
- UPMC Cancer Center at UPMC NorthwestRecruiting
- UPMC Uniontown Hospital Radiation OncologyRecruiting
- UPMC Washington Hospital Radiation OncologyRecruiting
- Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
- UPMC MemorialRecruiting
- Medical University of South Carolina
- Prisma Health Cancer Institute - Faris
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Gibbs Cancer Center-PelhamRecruiting
- Carolina Regional Cancer Center
- Spartanburg Medical CenterRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Vanderbilt University/Ingram Cancer CenterRecruiting
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- University of Texas Medical Branch
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
- Michael E DeBakey VA Medical CenterRecruiting
- UT Southwestern Clinical Center at Richardson/PlanoRecruiting
- Norris Cotton Cancer Center-NorthRecruiting
- Augusta Health Center for Cancer and Blood Disorders
- MultiCare Auburn Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical CenterRecruiting
- MultiCare Gig Harbor Medical Park
- Seattle Cancer Care Alliance at EvergreenHealthRecruiting
- MultiCare Good Samaritan Hospital
- Valley Medical CenterRecruiting
- FHCC South Lake UnionRecruiting
- University of Washington Medical Center - MontlakeRecruiting
- MultiCare Tacoma General Hospital
- West Virginia University HealthcareRecruiting
- Langlade Hospital and Cancer CenterRecruiting
- Ascension Saint Elizabeth HospitalRecruiting
- Northwest Wisconsin Cancer CenterRecruiting
- Aurora Cancer Care-Southern Lakes VLCCRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Mayo Clinic Health System-Eau Claire Clinic
- Aurora Health Care Germantown Health CenterRecruiting
- Aurora Cancer Care-GraftonRecruiting
- Bellin Memorial HospitalRecruiting
- Aurora BayCare Medical CenterRecruiting
- Aurora Cancer Care-Kenosha SouthRecruiting
- Mayo Clinic Health System-Franciscan Healthcare
- Aurora Bay Area Medical Group-MarinetteRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Aspirus Medford HospitalRecruiting
- Aurora Cancer Care-MilwaukeeRecruiting
- Aurora Saint Luke's Medical CenterRecruiting
- Aurora Sinai Medical CenterRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- Ascension Mercy HospitalRecruiting
- Vince Lombardi Cancer Clinic - OshkoshRecruiting
- Ascension All Saints HospitalRecruiting
- Aurora Cancer Care-RacineRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Vince Lombardi Cancer Clinic-SheboyganRecruiting
- Ascension Saint Michael's HospitalRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- Aurora Medical Center in SummitRecruiting
- Vince Lombardi Cancer Clinic-Two RiversRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Aurora Cancer Care-Milwaukee WestRecruiting
- Aurora West Allis Medical CenterRecruiting
- Diagnostic and Treatment CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (RT, chemotherapy)
Arm II (RT, chemotherapy, atezolizumab)
Patients undergo RT (3DCRT or IMRT) daily Monday-Friday for up to 7-8 weeks. Patients also receive chemotherapy based on physician's choice of gemcitabine IV twice weekly for 6 weeks concurrent with RT, or cisplatin IV weekly for 6 weeks concurrent with RT, or fluorouracil IV on same days as doses 1-5 and 16-20 of radiation therapy and mitomycin IV on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity. Patients also undergo a TURBT with bladder biopsy at randomization and week 18 as well as cystoscopy at randomization, at weeks 18, 30, 42, 54, then every 3 months through year 2, followed by every 6months through year 5 and CT or MRI at randomization, at weeks 18, 30, 42, 54, then every 6 months through year 2, followed by every 12 months through year 5.
Patients undergo RT (3DCRT or IMRT) daily Monday-Friday for up to 7-8 weeks and receive chemotherapy based on physician's choice as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo a TURBT with bladder biopsy at randomization and week 18 as well as cystoscopy at randomization, at weeks 18, 30, 42, 54, then every 3 months through year 2, followed by every 6months through year 5 and CT or MRI at randomization, at weeks 18, 30, 42, 54, then every 6 months through year 2, followed by every 12 months through year 5.