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Muscle Invasive Bladder Urothelial CarcinomaCancerProcedureDrugRadiationPhase 3

What this study is

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.

What's being tested

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo blood, tissue, and urine sample collection

  • Cisplatin

    Intervention · DRUG

  • Computed Tomography

    Intervention · PROCEDURE

    Undergo CT scan

  • Fluorouracil

    Intervention · DRUG

  • Gemcitabine

    Intervention · DRUG

  • Hypofractionated Radiation Therapy

    Intervention · RADIATION

    Undergo hypofractionated radiation therapy

  • Magnetic Resonance Imaging

    Intervention · PROCEDURE

    Undergo MRI

  • Mitomycin

    Intervention · DRUG

  • Positron Emission Tomography

    Intervention · PROCEDURE

    Undergo PET scan

  • Survey Administration

    Intervention · OTHER

    Ancillary studies

  • Ultrahypofractionated Radiation Therapy

    Intervention · RADIATION

    Undergo ultrahypofractionated radiation therapy.

All of Cisplatin, Fluorouracil, Gemcitabine, Mitomycin

Given IV

Study details

Official title
The Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (ARCHER)
Sponsor
NRG Oncology
Conditions
Muscle Invasive Bladder Urothelial Carcinoma · Stage II Bladder Cancer AJCC v8 · Stage IIIA Bladder Cancer AJCC v8
Enrolling
486 people
Starts
2025-10-07
Est. completion
2035-05-31
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗