Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT03775265
Collaborator
(none)
475
317
2
97.4
1.5
0

Study Details

Study Description

Brief Summary

This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

PRIMARY OBJECTIVE:
  1. To compare bladder intact event-free survival (BI-EFS) for concurrent chemoradiation therapy (CRT) with and without atezolizumab in localized muscle invasive bladder cancer (MIBC).
SECONDARY OBJECTIVES:
  1. To compare overall survival between the two arms. II. To compare modified bladder intact event-free survival including cancer related death between arms.

  2. To compare complete and partial pathologic response between arms at 3 months after completing chemoradiation therapy.

  3. To estimate metastases-free survival by arm. V. To compare the qualitative and quantitative adverse events from each arm. VI. To estimate the rate of non-muscle invasive bladder cancer recurrence by arm.

  4. To estimate the rate of salvage cystectomy and reasons for cystectomy by arm.

  5. To compare mean patient-reported global quality of life (QOL) at week 54 using the European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ)-Core (C)30 Global Health Status (GHS) subscale score between patients with localized muscle-invasive bladder cancer randomized to chemoradiation with versus (vs.) without atezolizumab.

TRANSLATIONAL MEDICINE OBJECTIVES:
  1. To test the hypothesis that a panel of validated biomarkers of concurrent CRT involving nuclear MRE11, impaired deoxyribonucleic acid damage response (DDR) function and tumor subtyping will be prognostic for BI-EFS among patients receiving either concurrent CRT or chemoimmuno-radiotherapy (CIRT) of the primary tumor.

  2. To test the hypothesis that tumor total mutation burden, neoantigen burden, infiltrating immune response, PD-L1 expression and T cell response are associated with augmented response after concurrent CIRT.

  3. To bank urine specimens for future use.

PATIENT-REPORTED OUTCOMES (PROs) OBJECTIVES:
  1. To compare mean patient-reported global QOL as measured by the EORTC QLQ-C30 Global Health Status subscale scores at week 54 between patients with localized muscle-invasive bladder cancer randomized to chemoradiation with versus without atezolizumab. (Primary) II. To compare mean patient-reported bowel symptoms at each assessment time by arm using the Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment from the Expanded Prostate Index, the bladder-specific supplement to the QLQ-C30, the EORTC QLQ-Muscle Invasive Bladder Cancer (BLM30), the Physical Functioning subscale of the EORTC QLQ-C30, and overall health status using the EuroQol Five Dimension Five Level Scale (EQ-5D-5L). (Exploratory) III. To compare longitudinal change over time by arm in patient-reported global QOL using the EORTC QLQ-C30, the Bowel Domain of the Expanded Prostate Index (EPIC Bowel Assessment), the bladder-specific supplement to the QLQ-C30, the EORTC QLQ-BLM30, the Physical Functioning subscale of the EORTC QLQ-C30, and overall health status using the EQ-5D-5L. (Exploratory)

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo radiation therapy (RT) (3 dimensional [D] CRT or intensity-modulated radiation therapy [IMRT]) daily Monday-Friday for up to 7-8 weeks. Patients also receive chemotherapy based on physician's choice of gemcitabine intravenously (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 transurethral resection of bladder tumor (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 6 months through year 5 and computed tomography (CT) or magnetic resonance imaging (MRI) at randomization, at weeks 18, 30, 42, 54, then every 6months through year 2, followed by every 12 months through year 5.

ARM II: 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 6 months through year 5 and CT or MRI at randomization, at weeks 18, 30, 42, 54, then every 6months through year 2, followed by every 12 months through year 5.

After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
475 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer
Actual Study Start Date :
Apr 19, 2019
Anticipated Primary Completion Date :
Jun 1, 2027
Anticipated Study Completion Date :
Jun 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (RT, chemotherapy)

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.

Procedure: Biopsy of Bladder
Undergo a bladder biopsy
Other Names:
  • Bladder Biopsy
  • Drug: Cisplatin
    Given IV
    Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
  • Procedure: Computed Tomography
    Undergo CT or MRI
    Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography
  • Procedure: Cystoscopy
    Undergo a cystoscopy

    Drug: Fluorouracil
    Given IV
    Other Names:
  • 5 Fluorouracil
  • 5 Fluorouracilum
  • 5 FU
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fluracil
  • 5-Fu
  • 5FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluracil
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
  • Drug: Gemcitabine
    Given IV
    Other Names:
  • dFdC
  • dFdCyd
  • Difluorodeoxycytidine
  • Procedure: Magnetic Resonance Imaging
    Undergo CT or MRI
    Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Drug: Mitomycin
    Given IV
    Other Names:
  • Ametycine
  • Jelmyto
  • MITO
  • Mito-C
  • Mito-Medac
  • Mitocin
  • Mitocin-C
  • Mitolem
  • Mitomycin C
  • Mitomycin-C
  • Mitomycin-X
  • Mitomycine C
  • Mitosol
  • Mitozytrex
  • Mutamycin
  • Mutamycine
  • NCI-C04706
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Radiation: Radiation Therapy
    Undergo 3DCRT or IMRT
    Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
  • Other: Survey Administration
    Ancillary studies

    Procedure: Transurethral Resection of Bladder Tumor
    Undergo a TURBT
    Other Names:
  • Transurethral resection (TURBT)
  • TURBT
  • Experimental: Arm II (RT, chemotherapy, atezolizumab)

    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.

    Drug: Atezolizumab
    Given IV
    Other Names:
  • MPDL 3280A
  • MPDL 328OA
  • MPDL-3280A
  • MPDL3280A
  • MPDL328OA
  • RG7446
  • RO5541267
  • Tecentriq
  • Procedure: Biopsy of Bladder
    Undergo a bladder biopsy
    Other Names:
  • Bladder Biopsy
  • Drug: Cisplatin
    Given IV
    Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
  • Procedure: Computed Tomography
    Undergo CT or MRI
    Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography
  • Procedure: Cystoscopy
    Undergo a cystoscopy

    Drug: Fluorouracil
    Given IV
    Other Names:
  • 5 Fluorouracil
  • 5 Fluorouracilum
  • 5 FU
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fluracil
  • 5-Fu
  • 5FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluracil
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
  • Drug: Gemcitabine
    Given IV
    Other Names:
  • dFdC
  • dFdCyd
  • Difluorodeoxycytidine
  • Procedure: Magnetic Resonance Imaging
    Undergo CT or MRI
    Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Drug: Mitomycin
    Given IV
    Other Names:
  • Ametycine
  • Jelmyto
  • MITO
  • Mito-C
  • Mito-Medac
  • Mitocin
  • Mitocin-C
  • Mitolem
  • Mitomycin C
  • Mitomycin-C
  • Mitomycin-X
  • Mitomycine C
  • Mitosol
  • Mitozytrex
  • Mutamycin
  • Mutamycine
  • NCI-C04706
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Radiation: Radiation Therapy
    Undergo 3DCRT or IMRT
    Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
  • Other: Survey Administration
    Ancillary studies

    Procedure: Transurethral Resection of Bladder Tumor
    Undergo a TURBT
    Other Names:
  • Transurethral resection (TURBT)
  • TURBT
  • Outcome Measures

    Primary Outcome Measures

    1. Bladder intact event-free survival (BI-EFS) [From the date of randomization to the first documentation of a BI-EFS event, assessed up to 5 years]

      At each time point, futility will be evaluated, and in the latter two analyses, efficacy will also be evaluated as specified. The final BI-EFS intent-to-treat analysis will be conducted using a stratified logrank test stratifying on stratification factors, and testing treatment at the one-sided significance level of 0.022 to account for multiple interim testing. The hazard ratio (HR) will be estimated using a stratified Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. Results from an unstratified analysis will also be provided. Kaplan-Meier methodology will be used to estimate the median BI-EFS for each treatment arm.

    Secondary Outcome Measures

    1. Overall survival (OS) [From date of randomization to death from any cause, assessed up to 5 years]

      Will be estimated using Kaplan-Meier methodology for each treatment arm. Will be analyzed using a similar method as for BI-EFS.

    2. Modified bladder intact event-free survival (mBI-EFS) [From date of randomization to the first documentation of a mBI-EFS event, assessed within 90 days]

      Analysis of modified BI-EFS, i.e., a sensitivity analysis of BI-EFS, where bladder cancer event is defined as histologically proven presence of muscle invasive bladder cancer, clinical evidence of nodal or metastatic disease, radical cystectomy, or death within 90 days of receiving protocol specified treatment, will also be conducted.

    3. Biopsy response [At 18 weeks]

      The Cochran-Mantel-Haenszel statistic will be used with modified ridit scores to evaluate the biopsy outcomes of complete response versus (vs.) down-staging vs. no response for the two treatment arms.

    4. Complete response duration [From the date of the biopsy documenting the complete response to the time of muscle invasive recurrence, local progression, evidence of metastatic disease or death due to any cause, assessed at 18 weeks]

      For the subset of patients who achieve a complete response during the week 18 biopsy window, complete response duration is defined from the date of the biopsy documenting the complete response to the time of muscle invasive recurrence, local progression, evidence of metastatic disease or death due to any cause. Will be analyzed using a similar method as for BI-EFS.

    5. Progression-free survival [From date of randomization to first radiologic or histologic evidence of local progression, nodal or distant metastasis, or death due to any cause, assessed up to 5 years]

      Will be estimated using Kaplan-Meier methodology for each treatment arm. Will be analyzed using a similar method as for BI-EFS.

    6. Metastasis-free survival [From date of randomization to first radiologic or histologic evidence of metastatic disease or death due to any cause, assessed up to 5 years]

      Will be estimated using Kaplan-Meier methodology for each treatment arm. Will be analyzed using a similar method as for BI-EFS.

    7. Cancer-specific survival [From date of randomization to date of death due to bladder cancer, assessed up to 5 years]

    8. Quality of life [Baseline up to 5 years]

      Assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)-C30. Will be examined using linear mixed models with patient considered as the random effect. The baseline physical function score and the stratification factors will be included in the regression model as adjustment covariates.

    Other Outcome Measures

    1. Treatment interactions [Up to 5 years]

      A Cox regression model will be used to evaluate the main effects of treatment arm and the main effect for each stratification factor and the interaction of the stratification factor with treatment in terms of both the primary endpoint and secondary endpoints. The stratification factors to be evaluated include: (1) clinical stage T2 vs. T3/T4a, (2) intended chemotherapy regimen cisplatin vs. 5-FU + mitomycin-C vs. gemcitabine, (3) radiation field small pelvis vs. bladder only and (4) performance status 0-1 vs. 2. There may be other radiation summary measures that may also be explored in terms of their modification of the experimental treatment effect including extent of radiation to lymph node fields. Subgroup analysis defined by stratification factors will also be conducted for primary endpoint and key secondary.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Hospital in Arizona Phoenix Arizona United States 85054
    2 Mayo Clinic in Arizona Scottsdale Arizona United States 85259
    3 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    4 University of Arizona Cancer Center-North Campus Tucson Arizona United States 85719
    5 Alta Bates Summit Medical Center-Herrick Campus Berkeley California United States 94704
    6 UC San Diego Moores Cancer Center La Jolla California United States 92093
    7 Los Angeles County-USC Medical Center Los Angeles California United States 90033
    8 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    9 Cedars Sinai Medical Center Los Angeles California United States 90048
    10 Fremont - Rideout Cancer Center Marysville California United States 95901
    11 UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California United States 92868
    12 Palo Alto Medical Foundation Health Care Palo Alto California United States 94301
    13 Sutter Roseville Medical Center Roseville California United States 95661
    14 Sutter Medical Center Sacramento Sacramento California United States 95816
    15 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    16 Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California United States 93401
    17 University of Colorado Hospital Aurora Colorado United States 80045
    18 Rocky Mountain Cancer Centers-Boulder Boulder Colorado United States 80304
    19 UCHealth Memorial Hospital Central Colorado Springs Colorado United States 80909
    20 Memorial Hospital North Colorado Springs Colorado United States 80920
    21 Shaw Cancer Center Edwards Colorado United States 81632
    22 Poudre Valley Hospital Fort Collins Colorado United States 80524
    23 Cancer Care and Hematology-Fort Collins Fort Collins Colorado United States 80528
    24 UCHealth Greeley Hospital Greeley Colorado United States 80631
    25 Medical Center of the Rockies Loveland Colorado United States 80538
    26 Smilow Cancer Hospital Care Center - Guiford Guilford Connecticut United States 06437
    27 Hartford Hospital Hartford Connecticut United States 06102
    28 Midstate Medical Center Meriden Connecticut United States 06451
    29 The Hospital of Central Connecticut New Britain Connecticut United States 06050
    30 Yale University New Haven Connecticut United States 06520
    31 Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut United States 06611
    32 Beebe South Coastal Health Campus Frankford Delaware United States 19945
    33 Helen F Graham Cancer Center Newark Delaware United States 19713
    34 Medical Oncology Hematology Consultants PA Newark Delaware United States 19713
    35 Beebe Health Campus Rehoboth Beach Delaware United States 19971
    36 Sibley Memorial Hospital Washington District of Columbia United States 20016
    37 Mount Sinai Comprehensive Cancer Center at Aventura Aventura Florida United States 33180
    38 UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida United States 33146
    39 UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida United States 33442
    40 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
    41 Mount Sinai Medical Center Miami Beach Florida United States 33140
    42 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    43 Moffitt Cancer Center Tampa Florida United States 33612
    44 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    45 Emory Saint Joseph's Hospital Atlanta Georgia United States 30342
    46 CTCA at Southeastern Regional Medical Center Newnan Georgia United States 30265
    47 Hawaii Cancer Care - Savio 'Aiea Hawaii United States 96701
    48 Pali Momi Medical Center 'Aiea Hawaii United States 96701
    49 The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii United States 96701
    50 Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii United States 96813
    51 Queen's Cancer Cenrer - POB I Honolulu Hawaii United States 96813
    52 Queen's Medical Center Honolulu Hawaii United States 96813
    53 Straub Clinic and Hospital Honolulu Hawaii United States 96813
    54 Queen's Cancer Center - Kuakini Honolulu Hawaii United States 96817
    55 The Cancer Center of Hawaii-Liliha Honolulu Hawaii United States 96817
    56 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    57 Illinois CancerCare-Canton Canton Illinois United States 61520
    58 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    59 Northwestern University Chicago Illinois United States 60611
    60 Rush University Medical Center Chicago Illinois United States 60612
    61 Decatur Memorial Hospital Decatur Illinois United States 62526
    62 Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois United States 60115
    63 Crossroads Cancer Center Effingham Illinois United States 62401
    64 Elmhurst Memorial Hospital Elmhurst Illinois United States 60126
    65 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    66 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    67 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    68 Northwestern Medicine Cancer Center Delnor Geneva Illinois United States 60134
    69 Edward Hines Jr VA Hospital Hines Illinois United States 60141
    70 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    71 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    72 Loyola University Medical Center Maywood Illinois United States 60153
    73 Edward Hospital/Cancer Center Naperville Illinois United States 60540
    74 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    75 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    76 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    77 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    78 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    79 Illinois CancerCare-Peru Peru Illinois United States 61354
    80 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    81 Springfield Clinic Springfield Illinois United States 62702
    82 Memorial Medical Center Springfield Illinois United States 62781
    83 Carle Cancer Center Urbana Illinois United States 61801
    84 Northwestern Medicine Cancer Center Warrenville Warrenville Illinois United States 60555
    85 Illinois CancerCare - Washington Washington Illinois United States 61571
    86 Community Cancer Center East Indianapolis Indiana United States 46219
    87 Community Cancer Center South Indianapolis Indiana United States 46227
    88 Community Cancer Center North Indianapolis Indiana United States 46256
    89 Reid Health Richmond Indiana United States 47374
    90 Mary Greeley Medical Center Ames Iowa United States 50010
    91 McFarland Clinic PC - Ames Ames Iowa United States 50010
    92 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    93 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    94 Greater Regional Medical Center Creston Iowa United States 50801
    95 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    96 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    97 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    98 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    99 University of Kansas Cancer Center Kansas City Kansas United States 66160
    100 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
    101 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
    102 Ascension Via Christi Hospitals Wichita Wichita Kansas United States 67214
    103 Baptist Health Lexington Lexington Kentucky United States 40503
    104 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    105 The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky United States 40202
    106 Baptist Health Louisville Louisville Kentucky United States 40207
    107 East Jefferson General Hospital Metairie Louisiana United States 70006
    108 LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie Louisiana United States 70006
    109 MaineHealth Coastal Cancer Treatment Center Bath Maine United States 04530
    110 Waldo County General Hospital Belfast Maine United States 04915
    111 MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine United States 04005
    112 Stephens Memorial Hospital Norway Maine United States 04268
    113 Maine Medical Center-Bramhall Campus Portland Maine United States 04102
    114 Penobscot Bay Medical Center Rockport Maine United States 04856
    115 MaineHealth Cancer Care Center of York County Sanford Maine United States 04073
    116 MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine United States 04073
    117 Maine Medical Center- Scarborough Campus Scarborough Maine United States 04074
    118 Maine Medical Partners - South Portland South Portland Maine United States 04106
    119 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
    120 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    121 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    122 Lowell General Hospital Lowell Massachusetts United States 01854
    123 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    124 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    125 Bronson Battle Creek Battle Creek Michigan United States 49017
    126 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
    127 University of Michigan - Brighton Center for Specialty Care Brighton Michigan United States 48116
    128 Saint Joseph Mercy Canton Canton Michigan United States 48188
    129 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
    130 GenesisCare USA - Clarkston Clarkston Michigan United States 48346
    131 Beaumont Hospital - Dearborn Dearborn Michigan United States 48124
    132 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    133 Henry Ford Hospital Detroit Michigan United States 48202
    134 Ascension Saint John Hospital Detroit Michigan United States 48236
    135 GenesisCare USA - Farmington Hills Farmington Hills Michigan United States 48334
    136 Weisberg Cancer Treatment Center Farmington Hills Michigan United States 48334
    137 Beaumont Hospital - Farmington Hills Farmington Hills Michigan United States 48336
    138 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    139 Sparrow Hospital Lansing Michigan United States 48912
    140 Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan United States 48154
    141 GenesisCare USA - Madison Heights Madison Heights Michigan United States 48071
    142 21st Century Oncology-Pontiac Pontiac Michigan United States 48341
    143 William Beaumont Hospital-Royal Oak Royal Oak Michigan United States 48073
    144 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    145 Munson Medical Center Traverse City Michigan United States 49684
    146 William Beaumont Hospital - Troy Troy Michigan United States 48085
    147 GenesisCare USA - Troy Troy Michigan United States 48098
    148 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    149 Henry Ford West Bloomfield Hospital West Bloomfield Michigan United States 48322
    150 Metro Health Hospital Wyoming Michigan United States 49519
    151 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
    152 Mercy Hospital Coon Rapids Minnesota United States 55433
    153 Miller-Dwan Hospital Duluth Minnesota United States 55805
    154 Fairview Southdale Hospital Edina Minnesota United States 55435
    155 Unity Hospital Fridley Minnesota United States 55432
    156 Monticello Cancer Center Monticello Minnesota United States 55362
    157 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    158 Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota United States 56303
    159 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    160 Regions Hospital Saint Paul Minnesota United States 55101
    161 Parkland Health Center-Bonne Terre Bonne Terre Missouri United States 63628
    162 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    163 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
    164 University of Kansas Cancer Center - North Kansas City Missouri United States 64154
    165 University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri United States 64064
    166 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    167 Washington University School of Medicine Saint Louis Missouri United States 63110
    168 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
    169 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    170 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    171 Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri United States 63376
    172 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    173 CoxHealth South Hospital Springfield Missouri United States 65807
    174 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
    175 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
    176 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    177 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    178 Nebraska Medicine-Bellevue Bellevue Nebraska United States 68123
    179 CHI Health Good Samaritan Kearney Nebraska United States 68847
    180 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    181 Nebraska Medicine-Village Pointe Omaha Nebraska United States 68118
    182 University of Nebraska Medical Center Omaha Nebraska United States 68198
    183 OptumCare Cancer Care at Charleston Las Vegas Nevada United States 89102
    184 Radiation Oncology Centers of Nevada Central Las Vegas Nevada United States 89106
    185 Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada United States 89128
    186 Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada United States 89144
    187 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
    188 OptumCare Cancer Care at Fort Apache Las Vegas Nevada United States 89148
    189 Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada United States 89169
    190 Renown Regional Medical Center Reno Nevada United States 89502
    191 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    192 Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
    193 Cooper Hospital University Medical Center Camden New Jersey United States 08103
    194 Hackensack University Medical Center Hackensack New Jersey United States 07601
    195 Memorial Sloan Kettering Monmouth Middletown New Jersey United States 07748
    196 Memorial Sloan Kettering Bergen Montvale New Jersey United States 07645
    197 MD Anderson Cancer Center at Cooper-Voorhees Voorhees New Jersey United States 08043
    198 Montefiore Medical Center-Einstein Campus Bronx New York United States 10461
    199 Montefiore Medical Center-Weiler Hospital Bronx New York United States 10461
    200 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
    201 Memorial Sloan Kettering Commack Commack New York United States 11725
    202 Memorial Sloan Kettering Westchester Harrison New York United States 10604
    203 Northwell Health/Center for Advanced Medicine Lake Success New York United States 11042
    204 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    205 Highland Hospital Rochester New York United States 14620
    206 University of Rochester Rochester New York United States 14642
    207 Phelps Memorial Hospital Center Sleepy Hollow New York United States 10591
    208 Stony Brook University Medical Center Stony Brook New York United States 11794
    209 State University of New York Upstate Medical University Syracuse New York United States 13210
    210 Memorial Sloan Kettering Nassau Uniondale New York United States 11553
    211 Good Samaritan Hospital Medical Center West Islip New York United States 11795
    212 Margaret R Pardee Memorial Hospital Hendersonville North Carolina United States 28791
    213 Vidant Oncology-Kenansville Kenansville North Carolina United States 28349
    214 Vidant Oncology-Kinston Kinston North Carolina United States 28501
    215 Vidant Oncology-Richlands Richlands North Carolina United States 28574
    216 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    217 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    218 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
    219 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    220 MetroHealth Medical Center Cleveland Ohio United States 44109
    221 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    222 Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio United States 45415
    223 Greater Dayton Cancer Center Kettering Ohio United States 45409
    224 Kettering Medical Center Kettering Ohio United States 45429
    225 University of Cincinnati Cancer Center-West Chester West Chester Ohio United States 45069
    226 Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma United States 73505
    227 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    228 Oregon Health and Science University Portland Oregon United States 97239
    229 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
    230 UPMC Altoona Altoona Pennsylvania United States 16601
    231 UPMC-Heritage Valley Health System Beaver Beaver Pennsylvania United States 15009
    232 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
    233 Carlisle Regional Cancer Center Carlisle Pennsylvania United States 17015
    234 Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania United States 19317
    235 Geisinger Medical Center Danville Pennsylvania United States 17822
    236 UPMC Hillman Cancer Center Erie Erie Pennsylvania United States 16505
    237 UPMC Cancer Center at UPMC Horizon Farrell Pennsylvania United States 16121
    238 UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania United States 15601
    239 UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania United States 17109
    240 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    241 UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown Pennsylvania United States 15901
    242 Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania United States 17837
    243 UPMC Cancer Center at UPMC McKeesport McKeesport Pennsylvania United States 15132
    244 UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg Pennsylvania United States 17050
    245 UPMC Cancer Center - Monroeville Monroeville Pennsylvania United States 15146
    246 UPMC-Coraopolis/Heritage Valley Radiation Oncology Moon Pennsylvania United States 15108
    247 UPMC-Magee Womens Hospital Pittsburgh Pennsylvania United States 15213
    248 UPMC-Saint Margaret Pittsburgh Pennsylvania United States 15215
    249 University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania United States 15232
    250 UPMC-Shadyside Hospital Pittsburgh Pennsylvania United States 15232
    251 UPMC-Passavant Hospital Pittsburgh Pennsylvania United States 15237
    252 UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania United States 15243
    253 UPMC Cancer Center at UPMC Northwest Seneca Pennsylvania United States 16346
    254 UPMC Uniontown Hospital Radiation Oncology Uniontown Pennsylvania United States 15401
    255 UPMC Washington Hospital Radiation Oncology Washington Pennsylvania United States 15301
    256 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
    257 UPMC Memorial York Pennsylvania United States 17408
    258 Medical University of South Carolina Charleston South Carolina United States 29425
    259 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    260 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    261 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    262 Carolina Regional Cancer Center Myrtle Beach South Carolina United States 29577
    263 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    264 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    265 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    266 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    267 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    268 University of Texas Medical Branch Galveston Texas United States 77555-0565
    269 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    270 Michael E DeBakey VA Medical Center Houston Texas United States 77030
    271 UT Southwestern Clinical Center at Richardson/Plano Richardson Texas United States 75080
    272 Augusta Health Center for Cancer and Blood Disorders Fishersville Virginia United States 22939
    273 MultiCare Auburn Medical Center Auburn Washington United States 98001
    274 Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington United States 98310
    275 Harrison Medical Center Bremerton Washington United States 98310
    276 MultiCare Gig Harbor Medical Park Gig Harbor Washington United States 98335
    277 Seattle Cancer Care Alliance at EvergreenHealth Kirkland Washington United States 98034
    278 MultiCare Good Samaritan Hospital Puyallup Washington United States 98372
    279 Seattle Cancer Care Alliance Seattle Washington United States 98109
    280 University of Washington Medical Center - Montlake Seattle Washington United States 98195
    281 MultiCare Tacoma General Hospital Tacoma Washington United States 98405
    282 West Virginia University Healthcare Morgantown West Virginia United States 26506
    283 Langlade Hospital and Cancer Center Antigo Wisconsin United States 54409
    284 Ascension Saint Elizabeth Hospital Appleton Wisconsin United States 54915
    285 Northwest Wisconsin Cancer Center Ashland Wisconsin United States 54806
    286 Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin United States 53105
    287 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    288 Mayo Clinic Health System-Eau Claire Clinic Eau Claire Wisconsin United States 54701
    289 Aurora Health Care Germantown Health Center Germantown Wisconsin United States 53022
    290 Aurora Cancer Care-Grafton Grafton Wisconsin United States 53024
    291 Bellin Memorial Hospital Green Bay Wisconsin United States 54301
    292 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
    293 Aurora Cancer Care-Kenosha South Kenosha Wisconsin United States 53142
    294 Mayo Clinic Health System-Franciscan Healthcare La Crosse Wisconsin United States 54601
    295 Aurora Bay Area Medical Group-Marinette Marinette Wisconsin United States 54143
    296 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    297 Aspirus Medford Hospital Medford Wisconsin United States 54451
    298 Aurora Cancer Care-Milwaukee Milwaukee Wisconsin United States 53209
    299 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
    300 Aurora Sinai Medical Center Milwaukee Wisconsin United States 53233
    301 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    302 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    303 Ascension Mercy Hospital Oshkosh Wisconsin United States 54904
    304 Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin United States 54904
    305 Ascension All Saints Hospital Racine Wisconsin United States 53405
    306 Aurora Cancer Care-Racine Racine Wisconsin United States 53406
    307 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    308 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
    309 Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin United States 54482
    310 Aurora Medical Center in Summit Summit Wisconsin United States 53066
    311 Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin United States 54241
    312 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
    313 Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin United States 53226
    314 Aurora West Allis Medical Center West Allis Wisconsin United States 53227
    315 Diagnostic and Treatment Center Weston Wisconsin United States 54476
    316 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
    317 Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin United States 54494

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Parminder Singh, Southwest Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT03775265
    Other Study ID Numbers:
    • NCI-2018-03264
    • NCI-2018-03264
    • S1806
    • S1806
    • U10CA180888
    First Posted:
    Dec 13, 2018
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2022