A phase III, multicentre randomised clinical trial comparing gemcitabine alone or in combination with capecitabine for the treatment of patients with advanced pancreatic cancer
| ISRCTN | ISRCTN11513444 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11513444 |
| ClinicalTrials.gov number | NCT00032175 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/09/2005
- Registration date
- 21/11/2005
- Last edited
- 09/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof David Cunningham
Scientific
Scientific
Department of Medicine
Royal Marsden Hospital
Downs Road
Sutton, Surrey
SM2 5PT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | GEMCAP |
| Study objectives | Does the addition of capecitabine to gemcitabine improve the survival or quality of life of patients with advanced pancreatic cancer? |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Advanced Pancreatic Cancer |
| Intervention | Arm 1: Gemcitabine 1000 mg/m^2 weeks 1-7 followed by a 1-week rest. Treatment will then adopt a 28 day cycle where gemcitabine, 1000 mg/m^2, will be given once weekly for 3 weeks followed by a 1-week rest. Arm 2: Treatment follows a 28 day cycle. Gemcitabine, 1000 mg/m^2, will be given weekly for 3 weeks followed by a 1-week rest. Capecitabine 830 mg/m^2 twice daily (total daily dose of 1660 mg/m^2) will be administered orally for 21 days followed by 7 days rest. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | capecitabine, gemcitabine |
| Primary outcome measure | One-year survival. |
| Secondary outcome measures | 1. Quality of life 2. Median and 2-year survival rates 3. Toxicity 4. Objective response rates 5. Assessment of pain |
| Overall study start date | 10/04/2002 |
| Completion date | 18/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 508 |
| Key inclusion criteria | 1. Age >18 years 2. Histologically or cytologically proven ductal adenocarcinoma or undifferentiated carcinoma of the pancreas 3. The presence of locally advanced or metastatic disease precluding curative surgical resection 4. Patients with macroscopic residual disease following resection confirmed by positive histology in post-resection tissue biopsies from the tumour bed (R2 resection) are also eligible 5. Unidimensionally measurable disease as assessed by computed tomography (CT) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. The only exception will be for patients with an R2 resection who will be evaluated for survival only. 6. No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication 7. No previous preoperative or adjuvant chemotherapy, radiotherapy or other investigational drug treatment 8. World Health Organisation (WHO) performance status 0, 1 or 2 9. Adequate bone marrow function with platelets >100 x 10^9/l; white blood cells (WBC) >3 x 10^9/l; neutrophils >1.5 x 10^9/l at the time of study entry 10. Serum bilirubin <35 µmol/l 11. Serum creatinine <180 µmol/l and calculated creatinine clearance over 50 ml/min 12. No concurrent uncontrolled medical condition 13. No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix 14. Life expectancy >3 months 15. Adequate contraceptive precautions if relevant 16. Informed written consent |
| Key exclusion criteria | 1. Medical or psychiatric conditions that compromise the patients ability to give informed consent 2. Intracerebral metastases or meningeal carcinomatosis 3. New York Heart Association classification Grade III or IV 4. Uncontrolled angina pectoris 5. Pregnancy or breast feeding 6. Impaired renal function with calculated creatinine clearance less than 50 ml/min 7. Previous investigational study drug 8. Known malabsorption syndromes 9. Patients with a known hypersensitivity to 5-FU or with a dihydropyrimidine dehydrogenase (DPD) deficiency |
| Date of first enrolment | 10/04/2002 |
| Date of final enrolment | 18/01/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Medicine
Sutton, Surrey
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Sponsor information
Sponsor not defined (UK)
Not defined
Not defined
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-
-
United Kingdom
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/11/2009 | Yes | No |
