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RECRUITING
NCT06214572
PHASE2/PHASE3

Radiation Therapy in Unresectable Gall Bladder Cancer

Sponsor: Tata Memorial Centre

View on ClinicalTrials.gov

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.

Official title: Systemic Therapy With or Without Radiation Therapy in Unresectable Nonmetastatic Gall Bladder Carcinoma: Open Label, Parallel Arm, Phase 2/3 Integrated Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

249

Start Date

2024-03-07

Completion Date

2029-07-21

Last Updated

2025-04-11

Healthy Volunteers

No

Interventions

DRUG

Systemic therapy (Gemcitabine plus Cisplatin)

Participants will receive one of the following Gemcitabine-based systemic therapy alone: Gemcitabine 1000mg/m2 and Cisplatin 25 mg/m2, each administered on Days 1 and 8 every 3 weeks (q3w) Duration: 3 months (in addition to 3 months previously received)

RADIATION

RT

Participants will receive radiation therapy in addition to systemic therapy Hypofractionated external image guided radiation to a dose of 40-55Gy in 10 sessions (up to 60Gy in 15 sessions) over 2-3 weeks. This is followed by systemic therapy as in the Systemic therapy alone arm.

DRUG

Systemic therapy (Gemcitabine plus oxaliplatin)

Gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 IV infusion on days 1 and 8 q2w. Duration: 3 months

DRUG

Systemic therapy (Gemcitabine plus Cisplatin plus Durvalumab)

Durvalumab 1500 mg via intravenous (IV) infusion q4w, starting on Cycle 1 in combination with cisplatin 25 mg/m2 and gemcitabine 1000 mg/m2 each administered on Days 1 and 8, q3w. Duration 3 months Durvalumab (12 months)

DRUG

Systemic therapy (Gemcitabine plus cisplatin plus nab-paclitaxel)

Gemcitabine 800 mg/m2, cisplatin, 25 mg/m2, and nab-paclitaxel 100 mg/m2, on days 1 and 8, q3w Duration: 3 months

Locations (1)

Tata Memorial Centre

Mumbai, Maharashtra, India