A randomised trial comparing 8 cycles of CPT11 with CPT11 until disease progression in patients with colorectal cancer resistant to 5-fluorouracil
| ISRCTN | ISRCTN59568483 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59568483 |
| Protocol serial number | RMH E/C 1475 |
| Sponsor | The Royal Marsden NHS Foundation Trust (UK) |
| Funder | Royal Marsden Hospital (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 15/12/2015
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised trial comparing 8 cycles of CPT11 with CPT11 until disease progression in patients with colorectal cancer resistant to 5-fluorouracil |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Colorectal cancer |
| Intervention | 1. CPT11 350 mg/m2 IV over 30 min every 3 weeks 2. No treatment |
| 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 | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | 1. Histological evidence of metastatic adenocarcinoma of colon or rectum not amenable to surgery or radiotherapy 2. Documented evidence of disease progression by Computed Tomography (CT) within 24 weeks of last 5FU |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 16/10/1997 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/12/2015: no publications found on PubMed.
