Radiation Therapy in Unresectable Gall Bladder Cancer

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

249

Participants

Timeline

Start Date

March 7, 2024

Primary Completion Date

July 21, 2029

Study Completion Date

July 21, 2029

Conditions
Gall Bladder Cancer
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

Trial Locations (1)

400012

RECRUITING

Tata Memorial Centre, Mumbai

All Listed Sponsors
lead

Tata Memorial Centre

OTHER