Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MA2B3002
Study information
Scientific title
A Prospective Randomised Multicentre Phase III Clinical Trial Comparing the Effects of Panorex Injection Plus 5-Fluorouracil (5-FU)/Leucovorin versus 5-Fluorouracil/Leucovorin versus PANOREX alone, in patients with Surgically resected Stage III (Dukes C) Carcinoma of the Colon
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Colon cancer
Intervention
1. Arm 1: Panorex (900 mg) (1 x 500 mg 5-FU, 4 x 100 mg Luecovorin)
2. Arm 2: 5-FU - 425 mg/m2/d x 5 days for six courses; Leucovorin - 20 mg.m2/day x 5 days for six courses
3. Arm 3: Panorex alone (900 mg)
Intervention type
Drug
Phase
Phase III
Drug names
edrecolomab (or Panorex)
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1998
Overall trial end date
12/03/1999
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histopathologically documented stage III (Dukes C) colon cancer
2. Less than 6 weeks since surgical removal of the tumour
3. Tumour-free margin of resection
4. Total resection of tumour by laparoscopy is an exclusion
5. Age >18: World Health Organisation (WHO) performance status of 0, 1 or 2: Life expectancy at least 12 months
6. Adequate haematological, hepatic and renal function
7. No metastatic, recurrent, locally advanced cancer or previous history of cancer
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
01/01/1998
Recruitment end date
12/03/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Glaxo Wellcome (UK)
Sponsor details
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
GlaxoSmithKline
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
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