Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RMH E/C 1041
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
As of 05/08/09 this trial was updated. All updates can be found under the relevant field with the above update date.
Ethics approval
Not provided at time of registration
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pancreatic cancer
Intervention
Two Arms:
1. Protracted venous infusion (PVI) 5FU 300 mg/m2/day over 24 weeks
2. PVI 5FU 300 mg/m2/day over 24 weeks MMC 7 mg/m2 (total dose not to exceed 56 mg) four courses over 24 weeks
Intervention type
Drug
Phase
Not Specified
Drug names
5-Fluorouracil (5FU), mitomycin-C
Primary outcome measure
Added 05/08/09:
1. tumour response
2. survival
3. toxicity
4. quality of life (QoL)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1995
Overall trial end date
31/12/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Histological evidence of locally advanced or metastatic carcinoma of the pancreas not amenable to surgery or radiotherapy. Alternatively patients would have radiologically measurable evidence of locally advanced or metastatic carcinoma of the pancreas not amenable to surgery or radiotherapy, without histological evidence but with a carcinoembryonic antigen (CEA) above 50.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Final recruitment: 208 (added 05/08/09)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/01/1995
Recruitment end date
31/12/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Funders
Funder type
Research organisation
Funder name
Royal Marsden Hospital NHS Foundation Trust (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
Basic results (scientific)
Publication list
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12118027
Publication citations
-
Results
Maisey N, Chau I, Cunningham D, Norman A, Seymour M, Hickish T, Iveson T, O'Brien M, Tebbutt N, Harrington A, Hill M, Multicenter randomized phase III trial comparing protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin in inoperable pancreatic cancer., J. Clin. Oncol., 2002, 20, 14, 3130-3136.