RecruitingPhase 2Phase 3NCT06214572

Radiation Therapy in Unresectable Gall Bladder Cancer

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


Sponsor

Tata Memorial Centre

Enrollment

249 participants

Start Date

Mar 7, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether radiation therapy (used alongside chemotherapy) can help treat gallbladder cancer that is too advanced to be removed by surgery. Gallbladder cancer is often diagnosed late when it has already grown into nearby blood vessels or the liver. Researchers want to see if radiation can shrink or control the tumor in patients who have already had some chemotherapy. **You may be eligible if...** - You are over 18 years old - You have gallbladder cancer confirmed by biopsy - Your cancer has not spread to distant organs - Your cancer is locally advanced — invading nearby blood vessels, the liver, or causing bile duct blockage - You had stable disease or partial response after 3 months of gemcitabine-based chemotherapy - You are in good enough health to tolerate chemotherapy and radiation - Your blood counts, kidney, and liver function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - Your overall health is too poor to safely receive chemotherapy or radiation - The radiation cannot be safely delivered due to the tumor's location relative to healthy tissue Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSystemic 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)

RADIATIONRT

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.

DRUGSystemic therapy (Gemcitabine plus oxaliplatin)

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

DRUGSystemic 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)

DRUGSystemic 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

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NCT06214572


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