Perioperative Therapy Preoperative Chemotherapy Versus Chemoradiotherapy in Locally Advanced Gall Bladder Cancers

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

September 6, 2016

Primary Completion Date

September 10, 2025

Study Completion Date

September 10, 2027

Conditions
Gall Bladder Cancers
Interventions
DRUG

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

DRUG

Cisplatin

Inj. cisplatin 25 mg/m2 delivered. day 1 and 8 every 3 weeks for 4 cycles

RADIATION

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).

PROCEDURE

PETCECT

All the patients will undergo PETCECT to rule out metastatic disease

PROCEDURE

Laparoscopy

Patients will be subjected to staging laparoscopy with 16b1 lymph node biopsy to rule out metastatic disease.

Trial Locations (1)

400012

Tata Memorial Centre, Mumbai

All Listed Sponsors
lead

Tata Memorial Hospital

OTHER_GOV

NCT02867865 - Perioperative Therapy Preoperative Chemotherapy Versus Chemoradiotherapy in Locally Advanced Gall Bladder Cancers | Biotech Hunter | Biotech Hunter