A randomised trial of CF (infusional 5-fluorouracil and cisplatin) alone versus CF plus concurrent radiotherapy in patients with locally advanced pancreatic carcinoma
| ISRCTN | ISRCTN54728875 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54728875 |
| Secondary identifying numbers | PANCRAD |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 24/10/2019
- 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) | Not specified |
| Study type | Not Specified |
| Scientific title | A randomised trial of CF (infusional 5-fluorouracil and cisplatin) alone versus CF plus concurrent radiotherapy in patients with locally advanced pancreatic carcinoma |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pancreas cancer |
| Intervention | 1. Regimen A: 5-fluorouracil, continuous infusion for 18 weeks, plus cisplatin repeated every 3 weeks for six cycles. 2. Regimen B: Cisplatin repeated every 3 weeks for four cycles plus 5-fluorouracil, continuous infusion for 12 weeks followed by continuous infusion for a further 6 weeks at a reduced dose. Radiotherapy 50 Gy in twenty-five fractions given over 5 weeks. Radiotherapy to commence on week 13 of chemotherapy. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cancer drugs |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1989 |
| Completion date | 11/11/1994 |
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 locally advanced or unresectable pancreatic adenocarcinoma 2. Patients evaluable for response must have bidmensionally measurable disease as assessed by Computed Tomography (CT) scans 3. No prior chemotherapy or radiotherapy 4. Life expectancy of >3 months 5. Adequate bone marrow and renal function 6. World Health Organisation (WHO) performance status 0-2 at randomisation 7. No medical contraindications to treatment protocols |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1989 |
| Date of final enrolment | 11/11/1994 |
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
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 |
Editorial Notes
24/10/2019: No publications found. All search options exhausted.
30/11/2015: No publications found in PubMed.
