A Randomised trial of Adjuvant Chemotherapy (ECF) in Biliary Cancer
| ISRCTN | ISRCTN18496239 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18496239 |
| Protocol serial number | RMH E/C 1325 |
| Sponsor | Royal Marsden Hospital (UK) |
| Funder | Royal Marsden Hospital (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 26/03/2020
- 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 | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A Randomised trial of Adjuvant Chemotherapy (ECF) in Biliary Cancer |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Biliary tract cancer |
| Intervention | Two Arms: 1. ECF - 5-Fluorouracil (5FU) 200 mg/m2 continuous infusion daily Epirubicin 50 mg/m2 3 weekly IV bolus Cisplatin 60 mg/m2 3 weekly 2. No treatment |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 28/02/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | 1. Histological confirmed carcinoma of biliary tract or gall bladder 2. Disease considered to have been completely resected 3. No metastases on staging |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 28/02/2002 |
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 | 01/09/1995 | 26/03/2020 | Yes | No |
Editorial Notes
26/03/2020: Publication reference added.
