EUCTR2007-004299-38-DE
Active, not recruiting
Phase 1
European Study Group for Pancreatic Cancer - Trial 4. Combination versus single agent adjuvant chemotherapy in resectable pancreatic ductal and peri-ampullary cancers. - ESPAC-4
The University of Liverpool0 sites1,068 target enrollmentMarch 3, 2011
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Resectable pancreatic cancer
- Sponsor
- The University of Liverpool
- Enrollment
- 1068
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.A) Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection)
- •B) 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 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, or equivalent value following local practice).
- •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
Similar Trials
Active, not recruiting
Not Applicable
A trial comparing the current standard treatment (gemcitabine) to the experimental, combined treatments of gemcitabine plus capecitabine.Resectable 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]EUCTR2007-004299-38-GBThe University of Liverpool1,396
Active, not recruiting
Phase 1
European Study Group for Pancreatic Cancer - Trial 4. Combination versus single agent adjuvant chemotherapy in resectable pancreatic cancer. - ESPAC-4Resectable pancreatic cancerMedDRA version: 14.1Level: LLTClassification code 10033602Term: Pancreatic adenocarcinoma resectableSystem Organ Class: 100000004864EUCTR2007-004299-38-SEThe University of Liverpool1,080
Active, not recruiting
Not Applicable
European Study Group for Pancreatic Cancer - Trial 4. Combination versus single agent adjuvant chemotherapy in resectable pancreatic cancer. - ESPAC-4Resectable pancreatic cancerMedDRA version: 9.1Level: LLTClassification code 10033602Term: Pancreatic adenocarcinoma resectableEUCTR2007-004299-38-FIThe University of Liverpool1,080
Not yet recruiting
Phase 3
Comparision of combination chemotherapy with single chemotherapy following Surgery for pancreatic and Periampullary cancerHealth Condition 1: null- pancreatic or peri-ampullary cancerCTRI/2017/10/010016Tata Memorial Hospital
Recruiting
Phase 2
PAT-07Borderline resectable pancreatic cancerBorderline resectable, pancreatic cancerD021441JPRN-jRCTs041200028Kodera Yasuhiro50