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ISRCTN
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ISRCTN69546136
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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ICCG/8/91
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Oesophagus, Stomach Cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/1996
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Anticipated end date
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01/01/1997
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Pharmacia and Upjohn Ltd (UK)
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Pharmacia Ltd & Upjohn (UK)
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Address
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Davy Avenue
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City/town
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Milton Keynes
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Zip/Postcode
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MK5 8PH
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Country
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United Kingdom
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Tel
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+44 (0)1908 661101
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Fax
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+44 (0)1908 690091
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Email
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Sponsor website:
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http://www.pharmacia.com
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Date applied
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19/08/2002
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Last edited
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07/08/2009
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Date ISRCTN assigned
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19/08/2002
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