A randomised study of continuous infusional 5-Fluorouracil (5FU) with or without bolus mitomycin-C in patients with carcinoma of unknown primary origin
| ISRCTN | ISRCTN63374575 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63374575 |
| Secondary identifying numbers | RMH E/N 1042 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 30/05/2012
- 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
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Multicentre 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 | Not provided at time of registration As of 05/08/09 this trial was updated. All updates can be found under the relevant field with the above update date. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Carcinoma of unknown primary origin |
| Intervention | 1. Regimen 1. Protracted Venous Infusion (PVI) 5FU 300 mg/m/day over 24 weeks 2. Regimen 2. PVI 5FU 300 mg/m/day over 24 weeks Mitomycin-C 7 mg/m (total not to 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 | Added 05/08/09: 1. tumour response 2. survival 3. toxicity 4. quality of life (QoL) |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1995 |
| Completion date | 30/04/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Final recruitment:88 (added 05/08/09) |
| Key inclusion criteria | 1. Histological evidence of carcinoma of unknown primary site 2. Patients evaluable for response 3. Must have bi-dimensionally measurable disease as assessed by chest X-ray or Computed Tomography (CT) scan 4. Disease must be outside previously irradiated areas |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1995 |
| Date of final enrolment | 30/04/2001 |
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
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
Research organisation
The Royal Marsden NHS Foundation Trust (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 | 01/05/2003 | Yes | No |
