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 |
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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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
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 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 type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Cancer drugs |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/1990 |
Completion date | 16/06/1995 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | Not provided at time of registration |
Key inclusion criteria | 1. 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 criteria | Not provided at time of registration |
Date of first enrolment | 01/01/1990 |
Date of final enrolment | 16/06/1995 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
Phone | +44 (0)207 317 5186 |
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kate.law@cancer.org.uk | |
Website | http://www.cancer.org.uk |
https://ror.org/054225q67 |
Funders
Funder type
Industry
Cancer Research UK
Private sector organisation / Other non-profit organizations
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 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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/01/1997 | Yes | No |