Histology based adjuvant chemotherapy in amPullary cancer phase II trial

Phase 2

• Conditions: Health Condition 1: C269- Malignant neoplasm of ill-definedsites within the digestive system

• Registration Number: CTRI/2020/05/025353
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

No radiological evidence of metastatic disease or and metastatic disease as discovered by on-table evaluation during definitive surgery for GBC peritoneal disease, liver metastases etc

-Histologically confirmed adenocarcinoma of the ampulla post resection with the following specifications

-Anatomical

-Growth in the lumen or walls of the distal ends intra-ampullary component) of the common bile duct (CBD) and or pancreatic duct, or

- Growth at the papilla of Vater, or

-Growth at the duodenal surface of the papilla (the duodenal-facing surface of the ampullary protuberance) with the ampullary orifice clearly located within this lesion.

-Stage as per AJCC 8th edition

Stage II

Stage III

-R0/R1 resection

-ECOG performance status 0 - 1

-Patient who can give informed consent for the study.

-Patient does not have any contraindications to receive chemotherapy.

-Duration between surgery and fitness for randomization to adjuvant therapy more than or equal to 90 days.

-Adequate hematological, hepatic and renal function parameters· Hematological- Hb more than 80 g/L, ANC more than equal to 1.5 x 109/L, platelets more than equal 100 x 109/L. Liver functions bilirubin less than or equal to 2 x upper limit normal (ULN), AST ALT less than equal to 5 x ULN, S. albumin more than equal to 30 g/L, Renal function Creatinine less than equal to 1.5 ULN, Creatinine clearance more than equal to 50 mL/min.

-Normal cardiac function, as assessed by echocardiography and ECG

-Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.

-Written patient consent form

Exclusion Criteria

-Resected Pancreatic cancers or resected patients with doubtful epicenter of primary

-R2 resections.

-Known hypersensitivity or contraindications against capecitabine, 5 FU, Irinotecan, or Oxaliplatin.

-Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV,

-Clinically significant valvular defect

-Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix

-Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy, NYHA ATS G2 and above

-Other severe internal disease or acute infection

-Baseline neuropathy more than NCI Grade I

-Chronic inflammatory bowel disease

-On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study

-Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified