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 |
| Secondary identifying numbers | RMH E/C 1475 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| 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 | 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 | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 16/10/1997 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
The Royal Marsden NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Downs Road
Sutton
SM2 5PT
England
United Kingdom
"ROR" |
https://ror.org/0008wzh48 |
|---|
Funders
Funder type
Hospital/treatment centre
Royal Marsden Hospital (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 |
Editorial Notes
15/12/2015: no publications found on PubMed.
