249
Participants
Start Date
March 7, 2024
Primary Completion Date
July 21, 2029
Study Completion Date
July 21, 2029
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)"
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."
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"
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)"
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
RECRUITING
Tata Memorial Centre, Mumbai
Tata Memorial Centre
OTHER