The Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (ARCHER)
NRG Oncology
Summary
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.
Description
PRIMARY OBJECTIVE: I. Demonstrate non-inferiority of ultra-hypofractionated (stereotactic body radiation therapy \[SBRT\]) compared to hypofractionated radiation therapy (RT) with a 10% non-inferiority margin (from 50% to 40%) in the rate of bladder-intact event-free survival (BI-EFS) at 3 years (corresponding to a hazard ratio \< 1.32). SECONDARY OBJECTIVES: I. Compare the rates of urinary and bowel toxicity, patient-reported outcomes (PRO), event-free survival (EFS), metastasis-free survival (MFS), and overall survival (OS) between the two treatment arms. II. Compare and evaluate symptom…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 transurethral resection of bladder tumor (TURBT) prior to randomization. Patients may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection * Must undergo radiological staging prior to randomization. Imaging of chest, abdomen, and pelvis must be per…
Interventions
- ProcedureBiospecimen Collection
Undergo blood, tissue, and urine sample collection
- DrugCisplatin
Given IV
- ProcedureComputed Tomography
Undergo CT scan
- DrugFluorouracil
Given IV
- DrugGemcitabine
Given IV
- RadiationHypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
- ProcedureMagnetic Resonance Imaging
Undergo MRI
Locations (211)
- Mercy Hospital Fort SmithFort Smith, Arkansas
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California
- UC San Diego Moores Cancer CenterLa Jolla, California
- UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California
- University of California Davis Comprehensive Cancer CenterSacramento, California
- UCHealth University of Colorado HospitalAurora, Colorado