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 |
| Protocol serial number | PETACC-1 |
| Sponsor | AstraZeneca Clinical Research Group (UK) |
| Funder | AstraZeneca Pharmaceuticals (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 16/07/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
