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 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
16/07/1999
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18707870
Publication citations
-
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.