About this trial
to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ECOG 0-2
Locally advanced resectable GBC defined as Clinical T3/4 disease or Regional LN involvement on imaging studies.
Post cholecystectomy GBC with residual disease on imaging, History of bile spillage during primary surgery , history of piece-meal removal of gall bladder during simple cholecystectomy, Regional LN involvement on imaging studies.
Disqualifiers
Early GBC ( cT1/T2) without significant lymphadenopathy or liver infiltration on radiological imaging .
Locally advanced disease requiring major hepatectomy or whipple's pancreatoduodenectomy.
Post cholecystectomy GBC without any evidence of spillage of residual disease on radiological imaging.
Obstructive jaundice due to involvement of biliary tree by tumour.
Trial design
Parallel
Treatments tested in this trial
neoadjuvant chemotherapy
DrugNACT group will receive gemcitabine and platinum combination. Most common regimen comprised of gemcitabine (1000 mg/ m2 intravenously over 30-60 min) on days 1 and 8, and cisplatin (75 mg/ m2 intravenously over 2 h) on day 1, every 21 days. In case of renal compromise, carboplatin was used. Response was assessed using CECT abdomen and PET scan. Chemotherapy related toxicity will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5 .0. PAtients will undergo curative surgery after neoadjuvant chemotherapy
curative surgery
Procedure/SurgeryPatient being taken up for surgical exploration will undergo staging laparoscopy followed by exploration and interaortocaval lymphnode sampling. After ruling out distant metastasis, local resectability will be reassessed and curative surgery will be performed. . Post-operative complications were recorded and graded according Clavien Dindo classification
Treatment groups
Trial outcomes
Primary outcomes
improvement in 3 year overall survival
To compare the 3 year overall survival with Neoadjuvant chemotherapy and surgery versus upfront surgery in locally advanced resectable gall bladder cancer
Secondary outcomes
post operative outcomes
To compare mortality and morbidity rate in two groups
Sponsors and contacts
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