124
Participants
Start Date
September 6, 2016
Primary Completion Date
September 10, 2025
Study Completion Date
September 10, 2027
Gemcitabine
Those randomized to systemic chemotherapy alone will proceed to receive Chemotherapy Gemcitabine gemcitabine 1000 mg/m2delivered day 1 and 8 every 3 weeks for 4 cycles
Cisplatin
Inj. cisplatin 25 mg/m2 delivered. day 1 and 8 every 3 weeks for 4 cycles
Chemoradiation
Radiotherapy will be for 5 weeks and will be given only in the study arm. The radiation dose will be 50-55 Gy/ 25 fractions to the gross disease and 45 Gy/ 25 fractions to suspected microscopic disease along with weekly gemcitabine (300 mg/ m2).
PETCECT
All the patients will undergo PETCECT to rule out metastatic disease
Laparoscopy
Patients will be subjected to staging laparoscopy with 16b1 lymph node biopsy to rule out metastatic disease.
Tata Memorial Centre, Mumbai
Tata Memorial Hospital
OTHER_GOV