Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GI33
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Cancer drugs
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1990
Overall trial end date
16/06/1995
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1990
Recruitment end date
16/06/1995
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Industry
Funder name
Cancer Research UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 1997 results in http://www.ncbi.nlm.nih.gov/pubmed/8996151
Publication citations
-
Results
Webb A, Cunningham D, Scarffe JH, Harper P, Norman A, Joffe JK, Hughes M, Mansi J, Findlay M, Hill A, Oates J, Nicolson M, Hickish T, O'Brien M, Iveson T, Watson M, Underhill C, Wardley A, Meehan M, Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer., J. Clin. Oncol., 1997, 15, 1, 261-267.