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Clinical Trials/CTRI/2011/12/002264
CTRI/2011/12/002264
Completed
Phase 2

Concurrent versus sequential neoadjuvant chemo-radiotherapy followed by surgery in operable carcinoma gallbladder patients: A pilot study

All India Institute of Medical Sciences0 sites16 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
All India Institute of Medical Sciences
Enrollment
16
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

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