To compare the Overall survival between the patients treated with neoadjuvant chemotherapy alone vs. patients treated with neoadjuvant chemoradiation.
- Conditions
- Health Condition 1: null- Gall Bladder cancer
- Registration Number
- CTRI/2016/08/007199
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 314
> 2 cm but < 5 cm liver invasion
Radiological involvement of antropyloric region of stomach, duodenum, hepatic flexure of colon or small intestine, but without infiltration of the mucosa on endoscopy.
Type I/II invasion â??Involvement of bile duct (common hepatic duct or proximal 1/3 of the common bile duct) on MRCP/PTBD causing obstructive jaundice
Radiological suspicion of lymph node involvement N1 {stations 8, 12, 13) Hepatic artery (Station 8), hepatoduodenal ligament (Station 12), retropancreatic/retroduodenal
(Station 13) i.e. size >1cm in short axis, round in shape, and heterogenous enhancement on PET scan.
Vascular involvement : impingement/ involvement ( <180 degree angle) of one or more of the following blood vessels CHA/RHA/MPV/RPV (stage III disease)
Patient who have undergone prior cholecystectomy having residual disease with at least one of the above features.
Biopsy/ FNAC proven adenocarcinoma
More than 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Normal hematological and renal and hepatic functions (serum bilirubin < 3mg/dl)
Resectable disease
Evidence of distant metastasis (Liver, Lung, peritoneum, port site etc)
Involving major part of the liver precluding restriction of full RT doses
Received any prior radiation or chemotherapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method