European Study Group for Pancreatic Cancer - Trial 4. Combination versus single agent adjuvant chemotherapy in resectable pancreatic cancer. - ESPAC-4

• Conditions: Resectable pancreatic cancer; MedDRA version: 9.1Level: LLTClassification code 10033602Term: Pancreatic adenocarcinoma resectable

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1080

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.Patients randomised within 12 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 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if combination chemotherapy (gemcitabine and capecitabine), when used as adjuvant therapy in patients following resection for pancreatic adenocarcinoma, improves survival over adjuvant therapy using gemcitabine alone.;Secondary Objective: 1. To compare the proportion of grade 3/4 toxicity across the treatment types.<br>2. To assess Quality of Life over time and treatment groups using the EORTC-C30 questionnaire.<br>3. To investigate and compare two year survival rates for the treatments.<br>4. To investigate and compare five year survival rates for the treatments. <br>5. To assess and compare relapse free survival (RFS).<br>;Primary end point(s): Length of survival. This measure is length of survival defined as number of days between date of randomisation and date of death due to any cause (event) or date of last follow-up if patient is still alive at time of analysis (censored).