A randomised study of continuous infusional 5-Fluorouracil (5FU) with or without mitomycin-C in patients with neuroendocrine tumours
| ISRCTN | ISRCTN53478221 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53478221 |
| Secondary identifying numbers | RMH E/N 1169 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 27/06/2012
- 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
Prof David Cunningham
Scientific
Scientific
Department of Medicine
Royal Marsden NHS Trust
Downs Road
Sutton
SM2 5PT
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 | |
| Study objectives | To compare the response rate and quality of life in patients having these regimens. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neuroendocrine tumours |
| Intervention | Two arms: Regimen 1. Protracted venous infusion (PVI) 5FU 300 mg/m2/day over 24 weeks Regimen 2. PVI 5FU 300 mg/m2/day over 24 weeks Mitomycin-C 7 mg/m2 (total dose must not exceed 56 mg) four courses over 24 weeks |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 5-Fluorouracil (5FU), mitomycin-C |
| Primary outcome measure | 1. Response rate 2. Toxicity 3. Time to disease progression 4. Survival 5. Quality of life |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 12/09/1995 |
| Completion date | 26/11/2003 |
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 neuroendocrine tumours not amenable to surgery or radiotherapy 2. Patients evaluable for response must have bi-dimensionally measurable disease as assessed by chest X-ray or computed tomography (CT) scan 3. This disease must be outside previously irradiated areas |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 12/09/1995 |
| Date of final enrolment | 26/11/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Medicine
Sutton
SM2 5PT
United Kingdom
SM2 5PT
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/07/2002 | Yes | No |
