Condition category
Cancer
Date applied
09/09/2005
Date assigned
21/11/2005
Last edited
09/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof David Cunningham

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00032175

Protocol/serial number

N/A

Study information

Scientific title

Acronym

GEMCAP

Study hypothesis

Does the addition of capecitabine to gemcitabine improve the survival or quality of life of patients with advanced pancreatic cancer?

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

capecitabine, gemcitabine

Primary outcome measures

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 trial start date

10/04/2002

Overall trial end date

18/01/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

508

Participant exclusion criteria

1. Medical or psychiatric conditions that compromise the patient’s 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

Recruitment start date

10/04/2002

Recruitment end date

18/01/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Medicine
Sutton, Surrey
SM2 5PT
United Kingdom

Sponsor information

Organisation

Sponsor not defined (UK)

Sponsor details

-
-
-
United Kingdom

Sponsor type

Not defined

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19858379

Publication citations

  1. Results

    Cunningham D, Chau I, Stocken DD, Valle JW, Smith D, Steward W, Harper PG, Dunn J, Tudur-Smith C, West J, Falk S, Crellin A, Adab F, Thompson J, Leonard P, Ostrowski J, Eatock M, Scheithauer W, Herrmann R, Neoptolemos JP, Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer., J. Clin. Oncol., 2009, 27, 33, 5513-5518, doi: 10.1200/JCO.2009.24.2446.

Additional files

Editorial Notes