Randomised trial comparing the efficacy of epirubicin, cisplatin and 5-fluorouracil (FEC) to 5-fluorouracil, methotrexate and adriamycin (FAMTX) in patients with gastric and oesophageal cancer

ISRCTN	ISRCTN37398231
DOI	https://doi.org/10.1186/ISRCTN37398231
Secondary identifying numbers	GI33

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)	Not specified
Study type	Not Specified
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Oesophagus, stomach cancer
Intervention	Patients are randomised to one of two chemotherapy regimens: 1. ECF Regimen: Multi-drug chemotherapy with epirubicin, cisplatin and 5-fluorouracil (FEC). Epirubicin and cisplatin repeated every 3 weeks for eight cycles. 5-Fluorouracil to be given by continuous infusion daily via central line for 21 weeks, stopping the day after the last cycle of cisplatin and epirubicin. 2. FAMTX Regimen: Multi-drug chemotherapy with methotrexate, adriamycin and 5-fluorouracil, cycle to be repeated every 28 days for six cycles.
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	01/01/1990
Completion date	16/06/1995

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. Histologically verified locally advanced or metastatic adenocarcinoma or undifferentiated carcinoma of the oesophagus or stomach 2. Bi-dimensionally measurable disease as assessed by Computed Tomography (CT), Magnetic Resonance Imaging (MRI) or radiography: evaluable disease; non-evaluable disease 3. No prior chemotherapy or radiotherapy 4. Adequate renal and hepatic function 5. Projected life expectancy of at least 3 months 6. No history of other malignant disease other than adequately treated non-melanotic skin cancer or in-situ carcinoma of the uterine cervix 7. No contraindications to treatment protocols
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1990
Date of final enrolment	16/06/1995

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Industry

Cancer Research UK
Private sector organisation / Other non-profit organizations

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	01/01/1997		Yes	No