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
Official title: The Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (ARCHER)
Is NCT07097142 recruiting? Yes, currently enrolling (Oct 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
Treatments studied
Chemotherapy
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage II, IIIA
Performance status
ZUBROD 0–2
Prior therapy
Cannot have received: 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 (transfusion/intervention allowed to achieve this level)
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 (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb]) ≥ 8.0 g/dl is acceptable) Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fairbanks Memorial Hospital · Fairbanks, Alaska
- Mercy Hospital Fort Smith · Fort Smith, Arkansas
- University of Arkansas for Medical Sciences · Little Rock, Arkansas
- Tower Cancer Research Foundation · Beverly Hills, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07097142 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior pelvic radiation disqualifies patients from enrollment.
What disease stage is eligible?
Stage II or IIIA is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages