Randomised phase II study of sequentially high dose Methotrexate and Fluorouracil combined with Epirubicin (FEMTX) versus FEMTX plus Cisplatin (FEMTX-P) in advanced gastric cancer

ISRCTN	ISRCTN69546136
DOI	https://doi.org/10.1186/ISRCTN69546136
Protocol serial number	ICCG/8/91
Sponsor	Pharmacia Ltd & Upjohn (UK)
Funder	Pharmacia and Upjohn Ltd (UK)

Submission date: 19/08/2002
Registration date: 19/08/2002
Last edited: 30/10/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

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

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised phase II study of sequentially high dose Methotrexate and Fluorouracil combined with Epirubicin (FEMTX) versus FEMTX plus Cisplatin (FEMTX-P) in advanced 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	Oesophagus, Stomach Cancer
Intervention	Patients are randomised to one of four treatment arms: 1. Arm A: Chemotherapy with FEMTX 2. Arm B: Chemotherapy with FEMTX plus Granulocyte Colony Stimulating Factor (G-CSF) 3. Arm C: Chemotherapy with FEMTX-P 4. Arm D: Chemotherapy with FEMTX-P plus G-CSF Centres may choose to randomise to Arms A and Arm C only. FEMTX: Chemotherapy with 5-flourouracil, high-dose methotrexate and epirubicin plus folinic acid rescue following methotrexate, a four week cycle given for a maximum of six cycles. FEMTX-P: Chemotherapy with 5-flourouracil, high-dose methotrexate, cisplatinum and epirubicin plus folinic acid rescue following methotrexate, a four week cycle given for a maximum of six cycles.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Methotrexate, fluorouracil, epirubicin and cisplatin
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/1997

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Key inclusion criteria	1. Aged less than 70 years 2. Histologically confirmed locally advanced and/or metastatic gastric cancer 3. Measurable or evaluable disease 4. Karnofsky status 80-100 5. Adequate renal, hepatic and bone marrow function
Key exclusion criteria	1. Previous chemotherapy or radiotherapy 2. Pleural or peritoneal effusions which cannot be adequately drained 3. Central Nervous System (CNS) metastases 4. History of previous or concomitant 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 5. Other medical contraindications to treatment protocols
Date of first enrolment	01/01/1996
Date of final enrolment	01/01/1997

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

30/10/2019: No publications found, all search options exhausted, study status unverified.
30/11/2015: No publications found in PubMed.