Pan-European Trials in Adjuvant Colon Cancer. PETACC-1: The Value of Tomudex Relative to Standard Leucovorin Modulated Bolus 5-Fluorouracil (5-FU)
| ISRCTN | ISRCTN72194324 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72194324 |
| Secondary identifying numbers | PETACC-1 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 14/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| 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 |
| 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 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1998 |
| Completion date | 16/07/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1998 |
| Date of final enrolment | 16/07/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
AstraZeneca Clinical Research Group (UK)
Industry
Industry
10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom
| Website | http://www.astrazeneca.co.uk |
|---|---|
"ROR" |
https://ror.org/04r9x1a08 |
Funders
Funder type
Industry
AstraZeneca Pharmaceuticals (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2008 | Yes | No |
