Study to assess whether preoperative chemotherapy in Periampullary carcinoma increases survival

Comparing survival outcomes between neoadjuvant chemotherapy vs upfront surgery in resectable periampullary carcinoma a prospective open label randomized controlled trial - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067431

Enrollment

272

Registered

2024-05-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C248- Malignant neoplasm of overlappingsites of biliary tract

Interventions

Intervention1: Neo adjuvant chemotherapy: GEM CAP regimen 1. Inj Gemcitabine 1000mg/m2 on day 1, 8. 2. Tab Capecitabine 650 mg/m2 BD on Day 1-14 Jaundiced patients will undergo biliary drainage proce

Eligibility

Inclusion criteria

Inclusion criteria: 1. Periampullary carcinoma which are resectable on imaging studies 2. ECOG grade 0-II 3. Biopsy proven periampullary carcinoma

Exclusion criteria

Exclusion criteria: 1. Borderline resectable and locally advanced disease 2. Contraindication to use of chemotherapy 3. Ca head of pancreas

Design outcomes

Secondary

Measure	Time frame
3. Overall survival in the two groups 4. Resection rate 5. R0 resection 6. Adverse events related to chemotherapy Timepoint: Overall survival at 5 years	—

Primary

Measure	Time frame
1.Local recurrence in the two groups 2.Distant metastasis in the two groupsTimepoint: Disease free survival at 2 years	—

Countries

India

Contacts

Public ContactDr Manasi Manasvi

AIIMS Patna

manasimanasvi01@gmail.com9680344995

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026