A trial comparing the current standard treatment (gemcitabine) to the experimental, combined treatments of gemcitabine plus capecitabine.

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10033602Term: Pancreatic adenocarcinoma resectableSystem Organ Class: 100000004864; Resectable pancreatic or peri-ampullary cancers; MedDRA version: 14.1Level: LLTClassification code 10034446Term: Periampullary carcinoma resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2007-004299-38-GB
• Lead Sponsor: The University of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-13
• Last Update Posted: 5 November 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1396

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.
10.Able to attend for administration of the adjuvant therapy.
11.Able to attend for long-term follow-up.
12.Life expectancy > 3 months.
13.No previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix).
14.No serious medical or psychological condition precluding adjuvant treatment.
15.Fully informed written consent given.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 810
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 586

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.
11.Patients with neutrophil counts of <1.5 x 10^9/l.
12.Patients with thrombocyte counts of <100 x 10^9/l.
13.Patients with severe hepatic impairment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified