An open, randomised, multicentre trial of Tomudex (ZD1694) versus 5-Fluorouracil (5-FU) and Leucovorin (LV) in patients with advanced colorectal carcinoma
ISRCTN | ISRCTN99195212 |
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DOI | https://doi.org/10.1186/ISRCTN99195212 |
Secondary identifying numbers | COLO2 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 11/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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 | Open randomised multicentre trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | An open, randomised, multicentre trial of Tomudex (ZD1694) versus 5-Fluorouracil (5-FU) and Leucovorin (LV) in patients with advanced colorectal carcinoma |
Study objectives | Not provided at time of registration |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Advanced colorectal carcinoma |
Intervention | 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. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | Raltitrexed (Tomudex®), leucovorin, 5-fluorouracil |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/2000 |
Completion date | 31/12/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Not provided at time of registration |
Key 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. Adequate bone marrow and liver function |
Key exclusion criteria | 1. Previous systemic chemotherapy for colorectal cancer 2. Concomitant use of any systemic anticancer therapy 3. Adjuvant chemotherapy within the last 12 months 4. Concomitant administration of folic acid other than the trial therapy 5. Known brain metastases 6. 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 7. Other medical contraindications to treatment |
Date of first enrolment | 01/01/2000 |
Date of final enrolment | 31/12/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
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 |
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https://ror.org/04r9x1a08 |
Funders
Funder type
Industry
AstraZeneca
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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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 |
Editorial Notes
11/01/2016: no publications found on PubMed.