Randomised trial comparing the efficacy of epirubicin, cisplatin and 5-fluorouracil (FEC) to 5-fluorouracil, methotrexate and adriamycin (FAMTX) in patients with gastric and oesophageal cancer

ISRCTN ISRCTN37398231
DOI https://doi.org/10.1186/ISRCTN37398231
Secondary identifying numbers GI33
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
04/01/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOesophagus, stomach cancer
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Cancer drugs
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1990
Completion date16/06/1995

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1990
Date of final enrolment16/06/1995

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Industry

Cancer Research UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/1997 Yes No