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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 |
| Source of record | UK Trials |
| ISRCTN | ISRCTN69546136 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | ICCG/8/91 |
| Public title | 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 |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Oesophagus, Stomach Cancer |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics information not required at time of registration. |
| Countries of trial | United Kingdom |
| Participants - 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 6. No previous chemotherapy or radiotherapy 7. No pleural or peritoneal effusions which cannot be adequately drained 8. No Central Nervous System (CNS) metastases 9. No 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 10. No medical contraindications to treatment protocols |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material | |
| Anticipated start date | 01/01/1996 |
| Anticipated end date | 01/01/1997 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| 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-CSF) 3. Arm C: Chemotherapy with FEMTX-P 4. Arm D: Chemotherapy with FEMTX-P plus G-CSF Centres may choose to randomise to Arms A and Arm C only. FEMTX: Chemotherapy with 5-flourouracil, high-dose methotrexate and epirubicin plus folinic acid rescue following methotrexate, a four week cycle given for a maximum of six cycles. FEMTX-P: Chemotherapy with 5-flourouracil, high-dose methotrexate, cisplatinum and epirubicin plus folinic acid rescue following methotrexate, a four week cycle given for a maximum of six cycles. |
| 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 Ltd (UK) |
| 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 | ISRCTN69546136 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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