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 (NCT)	NCT00032175
Protocol serial number	N/A
Sponsor	Sponsor not defined (UK)
Funder	Cancer Research UK (CRUK) (UK)

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

http://cancerhelp.cancerresearchuk.org/trials/single-or-combination-chemotherapy-for-patients-who-have-advanced-cancer-of-the-pancreas

Contact information

Prof David Cunningham
Scientific

Department of Medicine
Royal Marsden Hospital
Downs Road
Sutton, Surrey
SM2 5PT
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase III
Drug / device / biological / vaccine name(s)	capecitabine, gemcitabine
Primary outcome measure(s)	One-year survival.
Key secondary outcome measure(s)	1. Quality of life 2. Median and 2-year survival rates 3. Toxicity 4. Objective response rates 5. Assessment of pain
Completion date	18/01/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Department of Medicine

Sutton, Surrey
SM2 5PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/11/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes