Radiation Therapy in Unresectable Gall Bladder Cancer

Sponsor
Tata Memorial Centre
Study ID
NCT06214572
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Gall Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Systemic therapy (Gemcitabine plus Cisplatin) — DRUG
    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)
  • RT — RADIATION
    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.
  • Systemic therapy (Gemcitabine plus oxaliplatin) — DRUG
    Gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 IV infusion on days 1 and 8 q2w. Duration: 3 months
  • Systemic therapy (Gemcitabine plus Cisplatin plus Durvalumab) — DRUG
    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)
  • Systemic therapy (Gemcitabine plus cisplatin plus nab-paclitaxel) — DRUG
    Gemcitabine 800 mg/m2, cisplatin, 25 mg/m2, and nab-paclitaxel 100 mg/m2, on days 1 and 8, q3w Duration: 3 months

Study Details

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.

Key Dates

Start date
Mar 7, 2024
Status verified
Apr 2025
Primary completion
Jul 21, 2029
Completion
Jul 21, 2029

Study Design

Enrollment
249 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Systemic therapy
    Participants will receive one of the following Gemcitabine-based systemic therapy alone: 1. Gemcitabine plus cisplatin: Gemcitabine 1000mg/m2 and Cisplatin 25 mg/m2, each administered on Days 1 and 8 every 3 weeks (q3w) 2. Gemcitabine plus oxaliplatin: Gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 IV infusion on days 1 and 8 q2w. 3. 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. 4. 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
  • Active Comparator: RT (Radiation therapy)
    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 arm

Primary Outcome Measure

Median overall survival [ Time Frame: 2 years ]

Central Contacts

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