A trial comparing gemcitabine alone with gemcitabine and capecitabine together after surgery to remove cancer of the pancreas

Phase 3

Completed

• Conditions: Resectable pancreatic cancer; Cancer; Pancreatic cancer

• Registration Number: ISRCTN96397434
• Lead Sponsor: niversity of Liverpool and the Royal Liverpool and Broadgreen University Hospital NHS Trust (UK)

Brief Summary

2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28129987 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-08
• Study Completion: 2017-10-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 730

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 - CT scan within 3 months prior to randomisation
6. A World Health Organization performance status less than 2
7. Fully recovered from the operation and fit to take part in the trial
8. Able to attend for administration of the adjuvant therapy
9. Able to attend for long-term follow-up
10. Life expectancy greater than 3 months
11. No previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix)
12. No serious medical or psychological condition precluding adjuvant treatment
13. Fully informed written consent given

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 Tumor-Node-Metastasis (TNM) Stage IVb 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 31/05/2011:<br> Length of survival. Duration of follow-up: 60 months from randomisation.<br><br> Previous primary outcome measure:<br> Length of survival. Duration of follow-up: 60 months from the date of surgery.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Toxicity. Duration of follow-up: 60 months from the date of surgery.<br> 2. Quality of life, assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaires (EORTC C-30 QLQ) at baseline, 3, 6, 12, 16 and 24 months and annually thereafter up to 60 months<br> 3. Two-year survival<br> 4. Five-year survival<br> 5. Relapse free survival (RFS). Duration of follow-up: 60 months from the date of surgery.<br>