| Source of record | UK Trials |
| ISRCTN | ISRCTN71625775 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | ICCG/7/90 |
| Public title | 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 |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Oesophagus, Stomach |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 28/02/1998 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| 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 4 weeks of surgery.
2. Control Regimen: No further treatment. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Pharmacia and Upjohn |
| Sponsor name | Pharmacia Ltd (UK) |
| Sponsor details | Davy Avenue
Milton Keynes
United Kingdom
MK5 8PH |
| Sponsor telephone | +44 (0)1908 661101 |
| Sponsor fax | +44 (0)1908 690091 |
| Sponsor email | sponsor@unknown.com |
| Sponsor website | http://www.pharmacia.com |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN71625775 |
| Date last extracted from ISRCTN register | 17/04/2008 |
