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 3

Completed

• Conditions: Cancer of Oesophagus, Stomach; Cancer; Oesophagus, Stomach

• Registration Number: ISRCTN71625775
• Lead Sponsor: Pharmacia Ltd & Upjohn (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 1998-02-28
• Study Start: 2002-08-19
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified