Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ICCG/7/90
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
Cancer of Oesophagus, Stomach
Intervention
1. FEMTX Regimen: Chemotherapy, FEMTX (high dose methotrexate and 5-flourouracil with epirubicin) plus folinic acid rescue repeated every 28 days for six cycles. Chemotherapy should be started within 4 weeks of surgery.
2. Control Regimen: No further treatment.
Intervention type
Drug
Phase
Phase III
Drug names
High Dose Methotrexate and 5-Fluouracil Combined with Epirubicin (FEMTX)
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1993
Overall trial end date
28/02/1998
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologically proven adenocarcinoma of the stomach or distal oesophagus (oesophago-gastric junction provided the cardia is involved) treated by curative resection. The resection margins must be negative for tumour.
2. Pathologically stage T2, T3 or T4, T1 tumours are only included if lymph node involvement is demonstrated histologically, ie stage II or III
3. Adequate renal, hepatic and haematological function
4. No evidence of metastatic disease
5. Karnofsky score >70
6. No history of other malignancy, except squamous or basal cell carcinoma of the skin which has been effectively treated and carcinoma in situ of the cervix which has been treated operatively only
7. No previous or current non-malignant systemic disease (cardiovascular, renal, hepatic, etc) which would contraindicate the use of chemotherapy or prevent prolonged follow up
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
01/01/1993
Recruitment end date
28/02/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Pharmacia Ltd & Upjohn (UK)
Sponsor details
Davy Avenue
Milton Keynes
MK5 8PH
United Kingdom
+44 (0)1908 661101
info@adreco.co.uk
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Pharmacia and Upjohn (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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