drugset / Trial / NCT06214572

Radiation Therapy in Unresectable Gall Bladder Cancer

NCT06214572

Phase 2/3 Recruiting 249 enrolled Tata Memorial Centre
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to compare two treatment regimes, namely, systemic therapy (chemotherapy and/or immunotherapy) alone vs. systemic therapy and radiation therapy in patients with inoperable but localized gallbladder cancer. The main questions it aims to answer are: * Whether adding radiation therapy to systemic therapy improves overall survival? * What are the effects on other endpoints like cancer-free intervals, side effects, and quality of life? Participants will be randomly assigned to one of the two treatment regimes mentioned earlier by a computer-based program. Researchers will compare survival and quality of life outcomes between the two groups.

Timeline

Start
2024-03-07
Primary completion
2029-07-21
Completion
2029-07-21

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified 25 mg/m2
Comparator Durvalumab Monoclonal antibody 1500 mg Intravenous
Comparator Gemcitabine Small molecule 800 mg/m2
Comparator Gemcitabine Small molecule 1000 mg/m2
Comparator Oxaliplatin Small molecule 100 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 100 mg/m2

Indications