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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from May 31, 2030 to May 31, 2035 Site details revised at 1 of 211 sitesv5 Show 1 more changeShow less
    • Site details revised at 1 of 211 sites
  2. Site details revised at 1 of 211 sitesv4
  3. Trial sites expanded: 191 → 211 locations Start date changed from estimate of May 11, 2026 to Oct 7, 2025 · Secondary endpoints: 7 to 8v3 Show 2 more changesShow less
    • Start date changed from estimate of May 11, 2026 to Oct 7, 2025
    • Secondary endpoints: 7 to 8

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date: Aug 14, 2025 to May 11, 2026 · Interventions: Biospecimen Collection (Procedure), Cisplatin (Drug), Computed Tomography (Procedure), Fluorouracil (Drug), Gemcitabine (Drug)… to Biospecimen Collection (Procedure), Cisplatin (Drug), Computed Tomography (Procedure), Fluorouracil (Drug), Gemcitabine (Drug)… · Secondary endpoints: details revised at 1 of 7 entries · 2 morev2 Show 5 more changesShow less
    • Start date: Aug 14, 2025 to May 11, 2026
    • Interventions: Biospecimen Collection (Procedure), Cisplatin (Drug), Computed Tomography (Procedure), Fluorouracil (Drug), Gemcitabine (Drug)… to Biospecimen Collection (Procedure), Cisplatin (Drug), Computed Tomography (Procedure), Fluorouracil (Drug), Gemcitabine (Drug)…
    • Secondary endpoints: details revised at 1 of 7 entries
    • Study description expanded, about 421 words
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
NRG Oncology
67 trials monitored
See 5 trials at risk
Bladder Cancer
1,022 trials monitored
See 71 trials at risk
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.
Trial Details
NCT Number NCT07097142
Lead Sponsor NRG Oncology
Conditions Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8
Enrollment 486 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov