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NCT07097142 · ClinicalTrials.gov registry record · Phase 3
Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study
A Phase 3 study of Stage II Bladder Cancer AJCC v8 and Stage IIIA Bladder Cancer AJCC v8, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 486
- Enrollment target
- 20
- Study locations
NCT07097142: Recruiting Phase 3 study of Stage II Bladder Cancer AJCC v8 and Stage IIIA Bladder Cancer AJCC v8, sponsored by NRG Oncology.
NCT07097142 is a Phase 3 study of Stage II Bladder Cancer AJCC v8 and Stage IIIA Bladder Cancer AJCC v8 that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 486 participants, above the 230-participant average among 6 other Stage II Bladder Cancer AJCC v8 trials with a reported enrollment target (111% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07097142, a Phase 3 study of Stage II Bladder Cancer AJCC v8 and Stage IIIA Bladder Cancer AJCC v8, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 486 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect of decreased number of radiation (ultra-hypofractionated) treatments to the usual radiation number of treatments (hypofractionation) with standard of care chemotherapy, with cisplatin, gemcitabine or mitomycin and 5-fluorouracil for the treatment of patients with muscle invasive bladder cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a short period of time. Ultra-hypofractionated radiation therapy delivers radiation over an even shorter period of time than hypofractionated radiation therapy. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Chemotherapy drugs, such as mitomycin-C and 5-fluorouracil (5-FU), 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. Giving ultra-hypofractionated radiation may be equally effective as hypofractionated therapy for patients with muscle invasive bladder cancer.
Primary Outcome
Defined as histologically proven presence of muscle invasive bladder cancer (MIBC), radiographic evidence of nodal or metastatic disease, performance of radical cystectomy, or death from any cause. Time to event will be calculated from the date of randomization. BI-EFS will be estimated in the two treatment groups using the Kaplan-Meier method and the hazard ratio between ultra-hypofractionation and hypofractionation estimated by fitting a Cox proportional hazards regression model, including a t
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- DRUG Fluorouracil
- DRUG Gemcitabine
Study Locations (20)
Delaware
- Beebe Medical Center - Lewes
- Beebe South Coastal Health Campus - Millville
- Helen F Graham Cancer Center - Newark
- Medical Oncology Hematology Consultants PA - Newark
- Christiana Care Health System-Christiana Hospital - Newark
- Beebe Health Campus - Rehoboth Beach
- Christiana Care Health System-Wilmington Hospital - Wilmington
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- UM Sylvester Comprehensive Cancer Center at Doral - Doral
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- Miami Cancer Institute - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
Georgia
- Grady Health System - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 486 participants |
| Start Date | 2026-05-11 |
| Est. Completion | 2030-05-31 |
| Phase | Phase 3 |
What NCT07097142 shows while recruiting
NCT07097142 is an interventional study that assigns participants to a tested intervention. The registered 486 participants enrollment target is mid-sized for trials with a published cap, above the 230-participant average among 6 other Stage II Bladder Cancer AJCC v8 trials with a reported enrollment target (111% higher).
The record links to 3 conditions, with Stage II Bladder Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07097142 names 20 study sites across 5 states, led by Delaware, Florida, California.
Frequently Asked Questions
What is clinical trial NCT07097142 about?
NCT07097142 is a clinical study titled "Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study". This phase III trial compares the effect of decreased number of radiation (ultra-hypofractionated) treatments to the usual radiation number of treatments (hypofractionation) with standard of care chemotherapy, with cisplatin, gemcitabine or mitomycin and 5-fluorouracil for the treatment of patients ...
What is the current status of trial NCT07097142?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 486 participants. The study started on 2026-05-11. Estimated completion is 2030-05-31.
What conditions does trial NCT07097142 study?
This clinical trial studies the following conditions: Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8, Muscle Invasive Bladder Urothelial Carcinoma.
What interventions are being tested in trial NCT07097142?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Fluorouracil (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT07097142?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07097142 being conducted?
This trial has 20 study locations across Arkansas, California, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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