Histology based adjuvant chemotherapy in ampullary cancer a phase II trial
- Conditions
- Health Condition 1: C269- Malignant neoplasm of ill-definedsites within the digestive system
- Registration Number
- CTRI/2023/02/049494
- Lead Sponsor
- AIG Hospitals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Stage II
Stage III
-R0/R1 resection
-ECOG performance status 0-1
-Patient who give informed consent for the study.
-Patient does not have any contraindication 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 100 x 109/L, liver function bilirubin less than of 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 t 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 face of the trial.
-Written Patient consent form.
-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
-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
- Primary Outcome Measures
Name Time Method To evaluate whether histology based intensified adjuvant chemotherapy improves 2 year recurrence free survival as compared to historicals controlsTimepoint: 2 year recurrence free survival
- Secondary Outcome Measures
Name Time Method -Quality of life <br/ ><br>-Completion rates <br/ ><br>-Toxicity and side-effect profile in both arms <br/ ><br>-Recurrence patterns <br/ ><br> <br/ ><br>Timepoint: 7 years