Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PANCRAD
Study information
Scientific title
A Randomised Trial of CF (Infusional 5-Fluorouracil and Cisplatin) Alone versus CF Plus Concurrent Radiotherapy in Patients with Locally Advanced Pancreatic Carcinoma
Acronym
Study hypothesis
Not provided at time of registration
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
Not Specified
Patient information sheet
Condition
Pancreas cancer
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Cancer drugs
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1989
Overall trial end date
11/11/1994
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1989
Recruitment end date
11/11/1994
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Marsden Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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