Chemotherapy and Radiotherapy, given either together or sequentially, before surgery followed by surgery in operable cancer of gallbladder patients: A pilot study
- Conditions
- Health Condition 1: null- patients with operable carcinoma of Gall Bladder
- Registration Number
- CTRI/2011/12/002264
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
a) Subjects with FNAC-proven Gall bladder adenocarcinoma (up to operable stage IVA) which is potentially resectable by preoperative imaging
b) Performance status ECOG-1&2
c) Normal renal, hepatic, and hematologic function at the time of enrolment
d) Age 18-65 years
a) Patient refusal
b) Poor performance status (ECOG â?? 3&4)
c) Major co-morbid conditions like cirrhosis, renal failure, uncontrolled hypertension or cardiac failure -
d) Subjects who have received chemotherapy within 12 months prior to study entry.
e) Prior use of radiotherapy.
f) Subjects who have undergone previous surgery on gall bladder/biliary tree.
g) Any evidence of metastasis to distant organs (liver, lung, peritoneum).
h) Non-contiguous liver metastasis (M1 disease).
i) Major vascular involvement such as proper hepatic artery involvement and main portal vein involvement (T4 â?? inoperable disease).
j) Periaortic, Pericaval, Superior mesenteric artery and/or Celiac artery lymph node involvement (N2 disease) â?? confirmed by FNAC.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ability to achieve surgical resection <br/ ><br>Radiological response <br/ ><br> <br/ ><br>Timepoint: Ability to achieve surgical resection <br/ ><br>Radiological response <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Pathological response <br/ ><br>Toxicity <br/ ><br>Overall survival (OS) <br/ ><br>Timepoint: toxicity will be noted during and after chemoradiation, pathological response on histopathological examination of the resected specimen and OS at the end of two years