Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ICCG/8/91
Study information
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
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
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Methotrexate, fluorouracil, epirubicin and cisplatin
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1996
Overall trial end date
01/01/1997
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant 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
Recruitment start date
01/01/1996
Recruitment end date
01/01/1997
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 Ltd (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