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ISRCTN
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ISRCTN21587955
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ClinicalTrials.gov identifier
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Public title
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Randomised trial of adjuvant therapy in operable pancreatic cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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ESPAC-1
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom, Europe
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Disease/condition/study domain
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Cancer of pancreas
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Participants - inclusion criteria
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1. Histologically proven adenocarcinoma of the pancreas, macroscopically resected. (Patients with pancreatic cystadenocarcinoma and endocrine tumours, tumours of the pancreas and tumours of the duodenum, ampulla of Vater and lower common bile duct are excluded).
2. No evidence of ascities, metastases to the liver, spread to other distant abdominal organs, peritoneal or omental seedlings, or distant metastases
3. Fully recovered from the operation, fit to take part in the trial and life expectancy of more than 3 months
4. No previous or concurrent malignancy diagnosed, except basal cell carcinoma of skin or carcinoma in situ of cervix
5. No serious medical or psychological condition precluding adjuvant treatment
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1995
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Anticipated end date
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20/04/2000
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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All patients undergo surgical resection followed by randomisation to one of four treatment arms:
1. Arm A: Radiotherapy, a split course of 40 Gy with a 2 week separation between each 20 Gy segment. Each 20 Gy segment to be given in 2 Gy fractions over 2 weeks. Chemotherapy with 5-fluorouracil to be administered intravenously on each of the first 3 days of each 20 Gy segment of radiotherapy.
2. Arm B: Systemic therapy with folinic acid followed by 5-fluorouracil to be given on 5 consecutive days every 28 days for six cycles
3. Arm C: Radiotherapy, a split course of 40 Gy with a 2 week separation between each 20 Gy segment. Each 20 Gy segment to be given in 2 Gy fractions over 2 weeks. Radiotherapy to be followed by systemic therapy with folinic acid and 5-fluorouracil to be given on 5 consecutive days every 28 days for six cycles.
4. Arm D: Control, no further treatment
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK (CRUK) (UK)
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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14/08/2008
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Date ISRCTN assigned
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01/07/2001
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