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

AIG Hospitals0 sites0 target enrollmentStarted: TBDLast updated: March 6, 2023

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.
•\-Anatomically
•Growth in the lumen or walls of the distal ends intra ampullary component of the common bile duct. (CBD) and or pancreatic duct,
•\-Growth of the papilla of Vater, or
•Growth at the duodenal surface on the papilla (the duodenal facing surface of the ampullary protuberance) with the ampullary orifice clearly located with in the lesion.
•\-Stage as per AJCC 8th edition
•\-R0/R1 resection
•\-ECOG performance status 0\-1
•\-Patient who 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 dyspnoea 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 \> NCI Grade I
•\-Chronic inflammatory bowel disease

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