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NCT06770582 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial
A Phase 2 study of Stage I Bladder Cancer AJCC v8 and Non-Muscle Invasive Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT06770582: Recruiting Phase 2 study of Stage I Bladder Cancer AJCC v8 and Non-Muscle Invasive Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
NCT06770582 is a Phase 2 study of Stage I Bladder Cancer AJCC v8 and Non-Muscle Invasive Bladder Urothelial Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 160 participants, below the 197-participant average among 7 other Stage I Bladder Cancer AJCC v8 trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06770582, a Phase 2 study of Stage I Bladder Cancer AJCC v8 and Non-Muscle Invasive Bladder Urothelial Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving pembrolizumab with radiation may kill more tumor cells than chemotherapy with radiation therapy in patients with non-muscle invasive bladder cancer.
Primary Outcome
Defined as time free of histologically proven recurrent T1-T4 recurrence, clinical evidence of nodal or distant metastasis, radical cystectomy (either for disease progression or due to toxicity), or death from any cause. Analysis will consist of estimation of the BIEFS curves via the Kaplan-Meier estimator and testing of the primary hypothesis using the stratified logrank test (one-sided). Additionally, the Cox proportional hazards model will be used to estimate the hazard ratio adjusting for st
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- DRUG Fluorouracil
- DRUG Gemcitabine
Study Locations (20)
Illinois
- Rush MD Anderson Cancer Center - Chicago
- Carle at The Riverfront - Danville
- Cancer Care Specialists of Illinois - Decatur - Decatur
- Decatur Memorial Hospital - Decatur
- Carle Physician Group-Effingham - Effingham
- Crossroads Cancer Center - Effingham
- Carle Physician Group-Mattoon/Charleston - Mattoon
Georgia
- Grady Health System - Atlanta
- Emory Proton Therapy Center - Atlanta
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
California
- AIS Cancer Center at San Joaquin Community Hospital - Bakersfield
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
Delaware
- Helen F Graham Cancer Center - Newark
- Medical Oncology Hematology Consultants PA - Newark
Florida
- UF Health Cancer Institute - Gainesville - Gainesville
- Mount Sinai Medical Center - Miami Beach
Colorado
- Shaw Cancer Center - Edwards
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2025-06-03 |
| Est. Completion | 2032-02-01 |
| Phase | Phase 2 |
What NCT06770582 shows while recruiting
NCT06770582 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 197-participant average among 7 other Stage I Bladder Cancer AJCC v8 trials with a reported enrollment target (19% lower).
The record links to 3 conditions, with Stage I Bladder Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06770582 names 20 study sites across 6 states, led by Illinois, Georgia, California.
Frequently Asked Questions
What is clinical trial NCT06770582 about?
NCT06770582 is a clinical study titled "Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial". This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may h...
What is the current status of trial NCT06770582?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2025-06-03. Estimated completion is 2032-02-01.
What conditions does trial NCT06770582 study?
This clinical trial studies the following conditions: Stage I Bladder Cancer AJCC v8, Non-Muscle Invasive Bladder Urothelial Carcinoma, Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma.
What interventions are being tested in trial NCT06770582?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Fluorouracil (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT06770582?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06770582 being conducted?
This trial has 20 study locations across California, Colorado, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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