Radiation Therapy Options for Muscle Invasive Bladder Cancer

Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study

Recruiting Phase 3 Interventional Study
Muscle Invasive Bladder Urothelial Carcinoma Stage II Bladder Cancer AJCC v8 Stage IIIA Bladder Cancer AJCC v8
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
486 (estimated)
Sponsor
NRG Oncology · Other
Who this trial is looking for

This trial is looking for adults with muscle invasive bladder cancer. Participants will receive different amounts of radiation therapy while also getting standard chemotherapy treatment.

Are You a Good Fit for This Trial?
Must be taking CisplatinGemcitabineMitomycin5-Fluorouracil

You may be able to join if

  • I have been diagnosed with stage II or IIIA bladder cancer.
  • I have had a surgery to remove my bladder tumor.
  • I have undergone imaging tests that show no advanced disease.
  • I am at least 18 years old.
  • I have a performance status score of 2 or less.
  • I have normal blood counts.
  • I am not pregnant or nursing.
  • I have not had bladder cancer outside the bladder in the last 24 months.

You may not be able to join if

  • I have small cell carcinoma.
  • I have evidence of metastatic disease.
  • I have had prior pelvic radiation.
  • I have active infection requiring IV antibiotics.
  • I have hydronephrosis with kidney function not meeting requirements.
  • I have a history of cardiac disease affecting my ability to participate.
  • I have had severe reactions to previous therapies.
  • I have received neoadjuvant therapy beyond 180 days before this trial.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 rad…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Histologically proven, cT2-T3,N0M0 urothelial carcinoma of the bladder prior to randomization. * Note: Patients with mixed urothelial carcinoma will be eligible for the trial, but the presence of small cell carcinoma will make a patient ineligible * Must undergo a transuret…
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