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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN69546136
Enrollment
Unknown
Registered
2002-08-19
Start date
1996-01-01
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oesophagus, Stomach Cancer Cancer Malignant neopplasm of other or ill-defined digestive organs

Interventions

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

Sponsors

Pharmacia Ltd & Upjohn (UK)
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Secondary

MeasureTime frame
Not provided at time of registration

Primary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026