ISRCTN71625775CompletedPhase 3
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
Pharmacia Ltd & Upjohn (UK)0 sites0 target enrollmentStarted: August 19, 2002Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •Not provided at time of registration
Investigators
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