A trial comparing gemcitabine alone with gemcitabine and capecitabine toget... | Recruiting
A trial comparing gemcitabine alone... | Recruiting
A trial comparing gemcitabine alone with gemcitabine and capecitabine together after surgery to remove cancer of the pancreas
ESPAC-4

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Medical Conditions
  • Resectable pancreatic cancer
Primary Contact Details
Prof John Neoptolemos
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN96397434
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerhelp.org.uk/trials/a-trial-comparing-gemcitabine-alone-with-gemcitabine-and-capecitabine-together-after-surgery-to-remove-cancer-of-the-pancreas
Research Details
  • To investigate if combination chemotherapy (gemcitabine and capecitabine), when used as adjuvant therapy in patients following resection for pancreatic adenocarcinoma, improves survival over adjuvant therapy using gemcitabine alone.
Phase
Phase III
Study Design
Phase III international randomised controlled trial
Study Type
Interventional
Intervention

Gemcitabine and capecitabine versus gemcitabine alone

Gemcitabine administration:
1,000 mg/m^2 gemcitabine must be given as an intravenous infusion, the lyophilised powder being diluted in normal saline, over 30 minutes unless haematological toxicity occurs requiring dose adjustment. Administer on day 1, 8 and 15 (one cycle) for six cycles i.e. 24 weeks.

Capecitabine administration:
830 mg/m^2 capecitabine must be administered orally morning and evening daily (total daily dose of 1,660 mg/m^2) unless toxicity occurs requiring dose adjustment. The gemcitabine and capecitabine combination schedule used in this study originates from phase I data published by Schilsky et al. In this study the maximum tolerated dose was defined at gemcitabine 1 g/m^2 on days 1, 8 and 15, and capecitabine 1,660 mg/m^2/day given on days 1 - 21 every 28 days.

Intervention Type
Drug
Primary Outcome Measures
    Current primary outcome measure as of 31/05/2011:
    Length of survival. Duration of follow-up: 60 months from randomisation.

    Previous primary outcome measure:
    Length of survival. Duration of follow-up: 60 months from the date of surgery.
Secondary Outcome Measures
    1. Toxicity. Duration of follow-up: 60 months from the date of surgery.
    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
    3. Two-year survival
    4. Five-year survival
    5. Relapse free survival (RFS). Duration of follow-up: 60 months from the date of surgery.
Publication(s)
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28129987
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
722
Participant 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
Participant 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
-
Trial Contact(s)
Primary Trial Contact
Prof John Neoptolemos
Other Trial Contacts
Dr Karl Harvey
Countries Recruiting
France, Germany, Sweden, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
European Study Group for Pancreatic Cancer (ESPAC) - Trial 4: combination versus single agent adjuvant chemotherapy in resectable pancreatic cancer
EudraCT Number
2007-004299-38
Funder(s)
  • Cancer Research UK (CRUK) (UK) - funding the central co-ordination of the trial (the Liverpool Cancer Trials Unit) (grant ref: C245/A8968)
  • National Cancer Research Network (NCRN) nurse support at UK sites. Non-UK sites will be required to secure their own funding for participating in the trial.
Other Study ID Numbers
ESPAC-4
Sponsor(s)
University of Liverpool and the Royal Liverpool and Broadgreen University Hospital NHS Trust (UK)
Key Dates

Recruitment Start Date

13 Oct 2008

Recruitment End Date

31 Oct 2017

Trial Start Date

13 Oct 2008

Trial End Date

31 Oct 2017

Date added to source

08 Feb 2008

Date updated in source

30 Jan 2017