A Randomised trial of Adjuvant Chemotherapy (ECF) in Biliary Cancer

ISRCTN	ISRCTN18496239
DOI	https://doi.org/10.1186/ISRCTN18496239
Secondary identifying numbers	RMH E/C 1325

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2000
Completion date	28/02/2002

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 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

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Royal Marsden Hospital (UK)
Hospital/treatment centre

Downs Road
Sutton
SM2 5PT
England
United Kingdom

Hospital/treatment centre

Royal Marsden Hospital (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/1995	26/03/2020	Yes	No

26/03/2020: Publication reference added.