Adjuvant chemotherapy for operated amPullary AdenoCarcinomas based on Histology and Intensification â?? A two arm non - randomized open label prospective parallel adaptive design phase II clinical trial (APACHI)

Tata Memorial Hospital0 sites0 target enrollmentStarted: TBDLast updated: November 24, 2021

Overview

No summary available.

•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
•\-R0/R1 resection
•\-ECOG performance status 0 \- 1
•\-Patient who can give informed consent for the study.

•\-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

Sponsor