EUCTR2007-004299-38-GB
Active, not recruiting
Not Applicable
European Study Group for Pancreatic Cancer - Trial 4. Combination versus single agent chemotherapy in resectable pancreatic ductal and peri-ampullary cancers. - ESPAC-4
The University of Liverpool0 sites1,396 target enrollmentDecember 13, 2007
ConditionsResectable pancreatic or peri-ampullary cancersMedDRA version: 14.1Level: LLTClassification code 10033602Term: Pancreatic adenocarcinoma resectableSystem Organ Class: 100000004864MedDRA version: 14.1Level: LLTClassification code 10034446Term: Periampullary carcinoma resectableSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Resectable pancreatic or peri-ampullary cancers
- Sponsor
- The University of Liverpool
- Enrollment
- 1396
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1A.Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection).
- •1B.Patients who have undergone complete macroscopic resection for peri\-ampullary carcinoma (R0 or R1 resection).
- •2\.Completion of all pre\-operative investigations.
- •3\.Histological confirmation of the primary diagnosis.
- •4\.Histological examination of all resection margins.
- •5\.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.
- •6\.No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra\-abdominal organs – CT (chest, abdomen, pelvis) scan within 3 months prior to randomisation.
- •7\.A WHO performance status \< 2
- •8\.Creatinine clearance \= 50ml/min (according to Cockcroft and Gault)
- •9\.Fully recovered from the operation and fit to take part in the trial.
Exclusion Criteria
- •1\.Use of neo\-adjuvant chemotherapy or other concomitant chemotherapy.
- •2\.Patients with pancreatic lymphoma.
- •3\.Macroscopically remaining tumour (R2 resection).
- •4\.Patients with TNM Stage IV disease.
- •5\.Patients younger than 18 years.
- •6\.Pregnancy.
- •7\.New York Heart Association Classification Grade III or IV.
- •8\.Previous chemotherapy.
- •9\.All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.
- •10\.Patients with known malabsorption.
Outcomes
Primary Outcomes
Not specified
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