Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
14/07/2014
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

PETACC-1

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Colon

Intervention

1. Standard Arm: LV 20 mg/m2 iv bolus followed by 425 (or 370) mg/m2 5-FU iv bolus.
2. Experimental Arm: Tomudex 3.0 mg/m2 15 min iv infusion on day 1, repeated on day 22 for eight cycles (24 weeks). Day 1-21 is one cycle.

Intervention type

Other

Phase

Not Specified

Drug names

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

16/07/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with Dukes C Colon Cancer who have had a curative resection within 56 days and are fit for both treatments. Inclusion:
1. Written informed consent
2. Histologically confirmed Dukes C colon cancer
3. Curative radical resection within the last 56 days
4. Aged 18 years or over
5. World Health Organisation (WHO) performance status 0, 1

Participant type

Patient

Age group

Adult

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

16/07/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

AstraZeneca Clinical Research Group (UK)

Sponsor details

10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom

Sponsor type

Industry

Website

http://www.astrazeneca.co.uk

Funders

Funder type

Industry

Funder name

AstraZeneca Pharmaceuticals (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

2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18707870

Publication citations

  1. Results

    Popov I, Carrato A, Sobrero A, Vincent M, Kerr D, Labianca R, Raffaele Bianco A, El-Serafi M, Bedenne L, Paillot B, Mini E, Sanches E, Welch J, Collette L, Praet M, Wils J, Raltitrexed (Tomudex) versus standard leucovorin-modulated bolus 5-fluorouracil: Results from the randomised phase III Pan-European Trial in Adjuvant Colon Cancer 01 (PETACC-1)., Eur. J. Cancer, 2008, 44, 15, 2204-2211, doi: 10.1016/j.ejca.2008.07.002.

Additional files

Editorial Notes