A Prospective Randomised Multicentre Phase III Clinical Trial Comparing the Effects of Panorex Injection Plus 5-Fluorouracil (5-FU)/Leucovorin versus 5-Fluorouracil/Leucovorin versus PANOREX alone, in patients with Surgically resected Stage III (Dukes C) Carcinoma of the Colon
| ISRCTN | ISRCTN18439984 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18439984 |
| Secondary identifying numbers | MA2B3002 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 30/03/2020
- 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 |
| Scientific title | A Prospective Randomised Multicentre Phase III Clinical Trial Comparing the Effects of Panorex Injection Plus 5-Fluorouracil (5-FU)/Leucovorin versus 5-Fluorouracil/Leucovorin versus PANOREX alone, in patients with Surgically resected Stage III (Dukes C) Carcinoma of the Colon |
| 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 cancer |
| Intervention | 1. Arm 1: Panorex (900 mg) (1 x 500 mg 5-FU, 4 x 100 mg Luecovorin) 2. Arm 2: 5-FU - 425 mg/m2/d x 5 days for six courses; Leucovorin - 20 mg.m2/day x 5 days for six courses 3. Arm 3: Panorex alone (900 mg) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | edrecolomab (or Panorex) |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1998 |
| Completion date | 12/03/1999 |
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. Histopathologically documented stage III (Dukes C) colon cancer 2. Less than 6 weeks since surgical removal of the tumour 3. Tumour-free margin of resection 4. Total resection of tumour by laparoscopy is an exclusion 5. Age >18: World Health Organisation (WHO) performance status of 0, 1 or 2: Life expectancy at least 12 months 6. Adequate haematological, hepatic and renal function 7. No metastatic, recurrent, locally advanced cancer or previous history of cancer |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1998 |
| Date of final enrolment | 12/03/1999 |
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
Glaxo Wellcome (UK)
Industry
Industry
Stockley Park West
Uxbridge, Middlesex
UB11 1BT
United Kingdom
| Website | http://uk.gsk.com |
|---|---|
"ROR" |
https://ror.org/01xsqw823 |
Funders
Funder type
Industry
GlaxoSmithKline
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- GlaxoSmithKline plc., GSK plc., GSK
- 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 |
Editorial Notes
30/03/2020: No publications found. All search options exhausted.
