Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
21/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MA2B3002

Study information

Scientific title

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 measures

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

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

http://uk.gsk.com

Funders

Funder type

Industry

Funder name

GlaxoSmithKline

Alternative name(s)

GlaxoSmithKline Plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes