Pre and post operative chemotherapy with oxaliplatin, 5-Fluorouracil (5 FU)/Leucovorin (LV) versus surgery alone in resectable liver metastases from colorectal origin
| ISRCTN | ISRCTN55293778 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55293778 |
| ClinicalTrials.gov number | NCT00006479 |
| Secondary identifying numbers | EORTC/GITCCG 40983 |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 29/10/2013
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | Not Applicable |
| 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, rectum |
| Intervention | 1. Arm A: Oxaliplatin 85 mg/m2 (day 1) 5-FU: 2000 mg/m2/cycle (days 1 and 2), Leucovorin: 200 mg/m2 (day 1 and 2), every 2 weeks for 6 cycles before surgery and for 6 cycles following surgery. 2. Arm B: Surgery alone. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | oxaliplatin, 5-Fluorouracil (5 FU)/Leucovorin (LV) |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/2000 |
| Completion date | 02/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Added May 2008: 363 |
| Key inclusion criteria | 1. All potentially resectable liver metastases without detectable extra-hepatic tumour 2. Primary tumour resected or resectable 3. No previous chemotherapy with oxaliplatin |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2000 |
| Date of final enrolment | 02/07/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
| Phone | +44 (0)207 317 5186 |
|---|---|
| kate.law@cancer.org.uk | |
| Website | http://www.cancer.org.uk |
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2013 | Yes | No |
