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 |
| Protocol serial number | RMH E/C 1041 |
| Sponsor | The Royal Marsden NHS Foundation Trust (UK) |
| Funder | Royal Marsden Hospital NHS Foundation Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 5-Fluorouracil (5FU), mitomycin-C |
| Primary outcome measure(s) |
Added 05/08/09: |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 208 |
| 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
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
