|
ISRCTN
|
ISRCTN37398231
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
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
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
GI33
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Oesophagus, stomach cancer
|
|
Participants - 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
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/01/1990
|
|
Anticipated end date
|
16/06/1995
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Cancer Research UK
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
register@ctu.mrc.ac.uk
|
|
Sponsor
|
Cancer Research UK (CRUK) (UK)
|
|
Address
|
PO Box 123
Lincoln's Inn Fields
|
|
City/town
|
London
|
|
Zip/Postcode
|
WC2A 3PX
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7317 5186
|
|
Fax
|
+44 (0)20 7487 4302
|
|
Email
|
kate.law@cancer.org.uk
|
|
Sponsor website:
|
http://www.cancer.org.uk
|
|
Date applied
|
01/07/2001
|
|
Last edited
|
21/05/2008
|
|
Date ISRCTN assigned
|
01/07/2001
|
