OncoMatch/Clinical Trials/NCT07097142
Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study
Is NCT07097142 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Cisplatin and Fluorouracil for muscle invasive bladder urothelial carcinoma.
Treatment: Cisplatin · Fluorouracil · Gemcitabine · Mitomycin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Excluded: Stage NODE POSITIVE
cT2-T3,N0M0 urothelial carcinoma of the bladder prior to randomization. Patients must not have evidence of T4 or node positive disease.
Performance status
ZUBROD 0–2
Prior therapy
Must have received: transurethral resection of bladder tumor
Must undergo a transurethral resection of bladder tumor (TURBT) prior to randomization
Cannot have received: pelvic radiation
Must not have had prior pelvic radiation
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3; Platelets ≥ 100,000 cells/mm^3; Hemoglobin ≥ 8.0 g/dl
Kidney function
Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 2 x institutional upper limit of normal (ULN); AST and ALT ≤ 3 x institutional ULN
Cardiac function
New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible)
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3; Platelets ≥ 100,000 cells/mm^3; Hemoglobin ≥ 8.0 g/dl; Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula; Total bilirubin ≤ 2 x institutional upper limit of normal (ULN); AST and ALT ≤ 3 x institutional ULN; New York Heart Association Functional Classification II or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mercy Hospital Fort Smith · Fort Smith, Arkansas
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- UC San Diego Moores Cancer Center · La Jolla, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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