Study to assess whether preoperative chemotherapy in Periampullary carcinoma increases survival
Phase 3
- Conditions
- Health Condition 1: C248- Malignant neoplasm of overlappingsites of biliary tract
- Registration Number
- CTRI/2024/05/067431
- Lead Sponsor
- AIIMS PATNA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Periampullary carcinoma which are resectable on imaging studies
2.ECOG grade 0-II
3.Biopsy proven periampullary carcinoma
Exclusion Criteria
1.Borderline resectable and locally advanced disease
2.Contraindication to use of chemotherapy
3.Ca head of pancreas
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Local recurrence in the two groups <br/ ><br>2.Distant metastasis in the two groupsTimepoint: Disease free survival at 2 years <br/ ><br>
- Secondary Outcome Measures
Name Time Method 3.Overall survival in the two groups <br/ ><br>4.Resection rate <br/ ><br>5.R0 resection <br/ ><br>6.Adverse events related to chemotherapy <br/ ><br>Timepoint: Overall survival at 5 years