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NCT03775265 · ClinicalTrials.gov registry record · Phase 3
Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer
A Phase 3 study of Muscle-Invasive Bladder Carcinoma and Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 475
- Enrollment target
- 20
- Study locations
NCT03775265: Active Phase 3 study of Muscle-Invasive Bladder Carcinoma and Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
NCT03775265 is a Phase 3 study of Muscle-Invasive Bladder Carcinoma and Bladder Urothelial Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 475 participants, above the 92-participant average among 14 other Muscle-Invasive Bladder Carcinoma trials with a reported enrollment target (416% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03775265, a Phase 3 study of Muscle-Invasive Bladder Carcinoma and Bladder Urothelial Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 475 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- DRUG Atezolizumab
- DRUG Cisplatin
- PROCEDURE Cystoscopy
- PROCEDURE Biopsy of Bladder
Study Locations (20)
California
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- Mercy Cancer Center - Elk Grove - Elk Grove
- UC San Diego Moores Cancer Center - La Jolla
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Fremont - Rideout Cancer Center - Marysville
- Memorial Medical Center - Modesto
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Palo Alto Medical Foundation Health Care - Palo Alto
- Mercy Cancer Center - Rocklin - Rocklin
- Sutter Cancer Centers Radiation Oncology Services-Roseville - Roseville
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 475 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 3 |
What the registry record for NCT03775265 still lists
NCT03775265 is an interventional study that assigns participants to a tested intervention. The registered 475 participants enrollment target is mid-sized for trials with a published cap, above the 92-participant average among 14 other Muscle-Invasive Bladder Carcinoma trials with a reported enrollment target (416% higher).
The record links to 4 conditions, with Muscle-Invasive Bladder Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT03775265 names 20 study sites across 2 states, led by California, Arizona.
Frequently Asked Questions
What is clinical trial NCT03775265 about?
NCT03775265 is a clinical study titled "Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer". 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, cispl...
What is the current status of trial NCT03775265?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 475 participants. The study started on 2019-06-03. Estimated completion is 2027-06-01.
What conditions does trial NCT03775265 study?
This clinical trial studies the following conditions: Muscle-Invasive Bladder Carcinoma, Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8.
What interventions are being tested in trial NCT03775265?
The interventions under investigation include: Computed Tomography (PROCEDURE), Atezolizumab (DRUG), Cisplatin (DRUG), Cystoscopy (PROCEDURE), Biopsy of Bladder (PROCEDURE).
Who is sponsoring clinical trial NCT03775265?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03775265 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Muscle-Invasive Bladder Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03775265's enrollment target sits among peer trials
475 2nd of 14 the highest of 14 other Muscle-Invasive Bladder Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Muscle-Invasive Bladder Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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