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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	edrecolomab (or Panorex)
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	12/03/1999

Participant type(s)	Patient
Age group	Not Specified
Sex
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1998
Date of final enrolment	12/03/1999

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

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