A Randomised Study of continuous infusion 5-Fluorouracil (5FU) with or without bolus Mitomycin-C in Patients with Advanced Pancreatic Cancer
| ISRCTN | ISRCTN61961630 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61961630 |
| Secondary identifying numbers | RMH E/C 1041 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 07/06/2012
- 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
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 | Pancreatic cancer |
| Intervention | Two Arms: 1. Protracted venous infusion (PVI) 5FU 300 mg/m2/day over 24 weeks 2. PVI 5FU 300 mg/m2/day over 24 weeks MMC 7 mg/m2 (total dose 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 | 31/12/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Final recruitment: 208 (added 05/08/09) |
| Key inclusion criteria | Histological evidence of locally advanced or metastatic carcinoma of the pancreas not amenable to surgery or radiotherapy. Alternatively patients would have radiologically measurable evidence of locally advanced or metastatic carcinoma of the pancreas not amenable to surgery or radiotherapy, without histological evidence but with a carcinoembryonic antigen (CEA) above 50. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/01/1995 |
| Date of final enrolment | 31/12/2000 |
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
Royal Marsden Hospital 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 | 15/07/2002 | Yes | No |
