EUCTR2007-004299-38-SE
Active, not recruiting
Phase 1
European Study Group for Pancreatic Cancer - Trial 4. Combination versus single agent adjuvant chemotherapy in resectable pancreatic cancer. - ESPAC-4
The University of Liverpool0 sites1,080 target enrollmentJanuary 15, 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Resectable pancreatic cancer
- Sponsor
- The University of Liverpool
- Enrollment
- 1080
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (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\. No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra\-abdominal organs.
- •6\. A WHO performance status \< or equal to 2\.
- •7\. Creatinie clearence \> or equal to 50 ml/min (according to Cockcroft and Gault).
- •8\. Fully recovered from the operation and fit to take part in the trial.
- •9\. Able to attend for administration of the adjuvant therapy.
- •10\. Able to attend for long\-term follow\-up.
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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