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ISRCTN
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ISRCTN54728875
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ClinicalTrials.gov identifier
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Public title
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A Randomised Trial of CF (Infusional 5-Fluorouracil and Cisplatin) Alone versus CF Plus Concurrent Radiotherapy in Patients with Locally Advanced Pancreatic Carcinoma
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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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PANCRAD
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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
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Disease/condition/study domain
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Pancreas cancer
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Participants - inclusion criteria
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1. Histological evidence of locally advanced or unresectable pancreatic adenocarcinoma
2. Patients evaluable for response must have bidmensionally measurable disease as assessed by Computed Tomography (CT) scans
3. No prior chemotherapy or radiotherapy
4. Life expectancy of >3 months
5. Adequate bone marrow and renal function
6. World Health Organisation (WHO) performance status 0-2 at randomisation
7. No medical contraindications to treatment protocols
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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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01/01/1989
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Anticipated end date
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11/11/1994
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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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1. Regimen A: 5-fluorouracil, continuous infusion for 18 weeks, plus cisplatin repeated every 3 weeks for six cycles.
2. Regimen B: Cisplatin repeated every 3 weeks for four cycles plus 5-fluorouracil, continuous infusion for 12 weeks followed by continuous infusion for a further 6 weeks at a reduced dose. Radiotherapy 50 Gy in twenty-five fractions given over 5 weeks. Radiotherapy to commence on week 13 of chemotherapy.
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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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Royal Marsden Hospital (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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The Royal Marsden NHS Foundation Trust (UK)
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Address
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Downs Road
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City/town
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Sutton
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Zip/Postcode
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SM2 5PT
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Country
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United Kingdom
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Tel
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+44 (0)20 8661 3156
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Fax
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+44 (0)20 8643 9414
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Email
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Date applied
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19/08/2002
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Last edited
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23/05/2008
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Date ISRCTN assigned
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19/08/2002
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