Phase III Randomised Study of High Dose Methotrexate and 5-Fluouracil Combined with Epirubicin (FEMTX) versus No Treatment in Stage II-III Resected Gastric Cancer

ISRCTN	ISRCTN71625775
DOI	https://doi.org/10.1186/ISRCTN71625775
Secondary identifying numbers	ICCG/7/90

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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	Phase III Randomised Study of High Dose Methotrexate and 5-Fluouracil Combined with Epirubicin (FEMTX) versus No Treatment in Stage II-III Resected Gastric 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	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	High Dose Methotrexate and 5-Fluouracil Combined with Epirubicin (FEMTX)
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1993
Completion date	28/02/1998

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 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1993
Date of final enrolment	28/02/1998

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Pharmacia Ltd & Upjohn (UK)
Industry

Davy Avenue
Milton Keynes
MK5 8PH
United Kingdom

Industry

Pharmacia and Upjohn (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

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