Health Condition 1: null- pancreatic or peri-ampullary cancer
Conditions
Interventions
Intervention1: Gemcitabine and Capecitabine.: Arm 2
Gemcitabine 1000mg/m2 is given as an i.v. infusion over 30-45 minutes (or local practice), the lyophilized powder being diluted in normal saline. Th
this is to allow for public holidays or other miscellaneous reasons for a delay.
Capecitabine 1660mg/m2/day in two divided doses administered orally for 21 days followed by 7 daysâ?? rest (one cycle)
this is to allow for public holidays or other miscellaneous reasons for a delay.
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection). or Patients who have undergone complete macroscopic resection for peri-ampullary carcinoma (R0 or R1 resection). Completion of all pre-operative investigations. Histological confirmation of the primary diagnosis. 2) Histological examination of all resection margins. 3) Patients randomised ideally within 12 weeks of surgery, although case by case the CI will consider patients up to 14 weeks, and can begin treatment ideally within 14 weeks of surgery. 4)No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs â?? CT (chest, abdomen, pelvis) scan within 3 months prior to randomisation. 5) A WHO performance status 6) Creatinine clearance >= 50ml/min(according to Cockcroft and Gaultor equivalent value following local practice). 7) Fully recovered from the operation and fit to take part in the trial. 8) Able to attend for administration of the adjuvant therapy. 9)Able to attend for long-term follow-up. Life expectancy > 3 months. 10) No previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix). 11)No serious medical or psychological condition precluding adjuvant treatment. 12) Fully informed written consent given.
Exclusion criteria
Exclusion criteria: 1)Use of neo-adjuvant chemotherapy or other concomitant chemotherapy. 2)Patients with pancreatic lymphoma. Macroscopically remaining tumour (R2 resection). 3)Patients with TNM Stage IV disease. 4)Patients younger than 18 years. 5)Pregnancy. 6) New York Heart Association Classification Grade III or IV. 7)Previous chemotherapy. 8)All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom. 9)Patients with known malabsorption. 10)Patients with a baseline neutrophil count of Patients with a baseline platelet count of 11)Patients with severe hepatic impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pancreatic Ductal Adenocarcinoma Length of survival. Peri-Ampullary Carcinoma: Length of survival. Timepoint: Minimum 5 year till death | — |
Secondary
| Measure | Time frame |
|---|---|
| Pancreatic Ductal Adenocarcinoma: Toxicity Quality of life (assessed using the EORTC QLQ-C30 v3) Two year survival Five year survival Relapse free survival (RFS) Peri-Ampullary Carcinoma: Toxicity Quality of life Four year survival Relapse free survival (RFS)Timepoint: Minimum 5 year till death | — |
Countries
France, Germany, India, Other, Sweden, United Kingdom
Contacts
Public ContactShailesh Vinayak Shrikhande
Tata Memorial Hospital
Outcome results
None listed