Resectable pancreatic or peri-ampullary cancers MedDRA version: 14.1 Level: LLT Classification code 10033602 Term: Pancreatic adenocarcinoma resectable System Organ Class: 100000004864 MedDRA version: 14.1 Level: LLT Classification code 10034446 Term: Periampullary carcinoma resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Gemzar 200mg
Product Name: gemcitabine
Product Code: Gem
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: gemcitabine
CAS Number: 95058-81-4
Current Sponsor code:
Sponsors
The University of Liverpool
The Royal Liverpool and Broadgreen University Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if combination chemotherapy (gemcitabine and capecitabine), when used as adjuvant therapy in patients following resection for pancreatic ductal adenocarcinoma or peri-ampullary carcinoma, improves survival over adjuvant therapy using gemcitabine alone.;Secondary Objective: Pancreatic ductal adenocarcinoma patients: 1. To compare the proportion of grade 3/4 toxicity across the treatment types. 2. To assess Quality of Life over time and treatment groups using the EORTC-C30 questionnaire. 3. To investigate and compare two year survival rates for the treatments. 4. To investigate and compare five year survival rates for the treatments. 5. To assess and compare relapse free survival (RFS). Peri-ampullary carcinoma patients: 1. To compare the proportion of grade 3/4 toxicity across the treatment types. 2. To assess Quality of Life over time and treatment groups using the EORTC-C30 questionnaire. 3. To investigate and compare four year survival rates for the treatments. 4. To assess and compare relapse free survival (RFS).;Primary end point(s): Pancreatic ductal adenocarcinoma patients and peri-ampullary carcinoma patients: 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).;Timepoint(s) of evaluation of this end point: Pancreatic ductal adenocarcinoma patients: Two years and five years after the last patient has been recruited. Peri-ampullary carcinoma patients: Four years after the last patient has been recruited. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pancreatic ductal adenocarcinoma patients: 1. Toxicity 2. Quality of life 3. Two year survival 4. Five year survival 5. Relapse free survival (RFS) Peri-ampullary carcinoma patients: 1. Toxicity 2. Quality of life 3. Four year survival 4. Relapse free survival (RFS);Timepoint(s) of evaluation of this end point: Pancreatic ductal adenocarcinoma patients: Two years and five years after the last patient has been recruited. Peri-ampullary carcinoma patients: Four years after the last patient has been recruited. | — |
Countries
Finland, France, Germany, Hungary, Sweden, United Kingdom
Contacts
Public ContactDr. Seema Chauhan
Liverpool Cancer Trials Unit
Outcome results
None listed