Study Comparing Shorter Radiation Therapy to Standard Radiation with Chemotherapy for Bladder Cancer (ARCHER Study)

Program Overview

The ARCHER study is a Phase III trial that compares two different radiation therapy schedules for patients with muscle-invasive bladder cancer. One group will receive the usual radiation therapy over a longer period, while the other group will receive a shorter, more intense course of radiation. Both groups will also receive standard chemotherapy drugs, such as cisplatin, gemcitabine, or mitomycin with 5-fluorouracil. The study aims to find out if the shorter radiation schedule is just as effective as the longer one in controlling the cancer.

Description

The main goal of this study is to see if a shorter, more intense radiation therapy schedule (called ultra-hypofractionated radiation) is as effective as the usual longer schedule (hypofractionated radiation) in keeping the bladder cancer from coming back or spreading. Researchers will also compare side effects, quality of life, and survival rates between the two groups.

Participants will be randomly assigned to one of two groups:

• Group 1: Will receive the usual radiation therapy once a day, Monday to Friday, for 20 sessions, along with one of three chemotherapy regimens chosen by their doctor. They will also have regular scans and may provide blood and urine samples.

• Group 2: Will receive the shorter radiation therapy no more than twice a week for 5 sessions, along with one of three chemotherapy regimens chosen by their doctor. They will also have regular scans and may provide blood and urine samples.

After completing the treatment, participants will have follow-up visits at week 16, every 3 months for 3 years, and then every 6 months up to 5 years.

Eligibility Criteria

Locations