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| An open, randomised, multicentre trial of Tomudex (ZD1694) versus 5-Fluorouracil (5-FU) and Leucovorin (LV) in patients with advanced colorectal carcinoma |
| Source of record | UK Trials |
| ISRCTN | ISRCTN99195212 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | COLO2 |
| Public title | An open, randomised, multicentre trial of Tomudex (ZD1694) versus 5-Fluorouracil (5-FU) and Leucovorin (LV) in patients with advanced colorectal carcinoma |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Colon, Rectum |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Microscopically confirmed adenocarcinoma of the colon or rectum 2. Locally advanced, or metastatic (Dukes stage D) disease for which no curative therapy is available 3. Aged over 18 years 4. One or more measurable or evaluable lesions 5. World Health Organisation (WHO) performance status 0-2 6. Life expectancy of at least three months 7. No previous systemic chemotherapy for colorectal cancer 8. No concomitant use of any systemic anticancer therapy 9. No adjuvant chemotherapy within the last 12 months 10. No concomitant administration of folic acid other than the trial therapy 11. No known brain metastases 12. Adequate bone marrow and liver function 13. No previous or concurrent malignancies at other sites, except adequately treated in-situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin 14. No medical contraindications to treatment |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material | |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. Treatment A: Tomudex, a single dose repeated every three weeks until disease progression, unacceptable toxicity or proof of no clinical benefit to the patient. 2. Treatment B: Leucovorin followed by 5-fluorouracil daily for five days, repeated at week four, week eight and every five weeks thereafter until disease progression, unacceptable toxicity or proof of no clinical benefit to the patient. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | AstraZeneca Pharmaceuticals |
| Sponsor name | AstraZeneca Clinical Research Group (UK) |
| Sponsor details | 10 Logie Mill Beaverbank Office Park Lovie Green Road Edinburgh United Kingdom EH7 4HG |
| Sponsor telephone | +44(0)1316523000 |
| Sponsor fax | +44(0)1315574858 |
| Sponsor email | sponsor@unknown.com |
| Sponsor website | http://www.astrazeneca.co.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator MRC Clinical Trials Unit 222 Euston Road London United Kingdom NW1 2DA |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN99195212 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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