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Clinical Trials/CTRI/2023/07/055908
CTRI/2023/07/055908
Not yet recruiting
Phase 3

Comparison of Adjuvant Chemoradiotherapy versus Adjuvant Chemotherapy in carcinoma gall bladder- A phase III randomized controlled study - CRT-GB

All India Institute of Medical Sciences Bhubaneswar0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: C23- Malignant neoplasm of gallbladder

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: C23- Malignant neoplasm of gallbladder
Sponsor
All India Institute of Medical Sciences Bhubaneswar
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

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

Investigators

Sponsor
All India Institute of Medical Sciences Bhubaneswar

Eligibility Criteria

Inclusion Criteria

  • •1\. Eastern Cooperative Oncology Group (ECOG) Performance Score\- 0\-1
  • •2\. Newly diagnosed, primary gall bladder adenocarcinoma, after radical cholecystectomy with at least one of the following criteria:
  • •i. PT3 or PT4
  • •ii. Lymph node\-positive
  • •iii. Margin positive
  • •iv. PT2 with lymphovascular invasion (LVI) or perineural invasion (PNI) or poorly differentiated tumor.
  • •3\. Hematological parameters, liver function test, Kidney function test, and cardiac function within normal limits.

Exclusion Criteria

  • •1\. Inoperable carcinoma gall bladder or with metastasis
  • •2\. Previous history of any treatment (chemotherapy, radiotherapy or surgery) for cancer
  • •3\. Previous radiotherapy to the abdominal or pelvic region
  • •4\. Recurrent gall bladder carcinoma
  • •5\. ECOG performance score 2\-4
  • •6\. Clinically significant cardiac disease and liver dysfunction
  • •7\. Pregnant patients

Outcomes

Primary Outcomes

Not specified

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