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Phase III Randomised Study of High Dose Methotrexate and 5-Fluouracil Combined with Epirubicin (FEMTX) versus No Treatment in Stage II-III Resected Gastric Cancer

Phase III Randomised Study of High Dose Methotrexate and 5-Fluouracil Combined with Epirubicin (FEMTX) versus No Treatment in Stage II-III Resected Gastric Cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN71625775
Enrollment
Unknown
Registered
2002-08-19
Start date
1993-01-01
Completion date
Unknown
Last updated
2020-01-06

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

Conditions

Cancer of Oesophagus, Stomach Cancer Oesophagus, Stomach

Interventions

1. FEMTX Regimen: Chemotherapy, FEMTX (high dose methotrexate and 5-flourouracil with epirubicin) plus folinic acid rescue repeated every 28 days for six cycles. Chemotherapy should be started within

Sponsors

Pharmacia Ltd & Upjohn (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically proven adenocarcinoma of the stomach or distal oesophagus (oesophago-gastric junction provided the cardia is involved) treated by curative resection. The resection margins must be negative for tumour. 2. Pathologically stage T2, T3 or T4, T1 tumours are only included if lymph node involvement is demonstrated histologically, ie stage II or III 3. Adequate renal, hepatic and haematological function 4. No evidence of metastatic disease 5. Karnofsky score >70 6. No history of other 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 7. No previous or current non-malignant systemic disease (cardiovascular, renal, hepatic, etc) which would contraindicate the use of chemotherapy or prevent prolonged follow up

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

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