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| Adjuvant 5-Fluorouracil, 4-Epidoxorubicin and Cyclophosphamide (FEC) versus Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Premenopausal Node Positive Primary Breast Cancer |
| Source of record | UK Trials |
| ISRCTN | ISRCTN27799222 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | ICCG/2/84 |
| Public title | Adjuvant 5-Fluorouracil, 4-Epidoxorubicin and Cyclophosphamide (FEC) versus Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Premenopausal Node Positive Primary Breast Cancer |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Breast |
| 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. Aged <65 years 2. Tumour confined to the breast or breast and ipsilateral axilla and considered operable 3. At least one axillary lymph node must show evidence of tumour on histological examination 4. On clinical examination, the axillary nodes should be moveable in relation to the chest wall and neurovascular bundle, and there should be no oedema of the arm 5. Adequate renal, hepatic and haematological function 6. No previous oophorectomy for breast carcinoma 7. No evidence of metastatic disease 8. Patients with advanced disease or ulceration, erythema, infiltration of the skin and oedema are ineligible 9. No previous concomitant malignancy, except squamous or basal cell carcinoma of the skin or carcinoma in-situ of the cervix 10. No non-malignant systemic disease which would preclude the use of any treatment within the trial |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material | |
| Anticipated start date | 01/01/1987 |
| Anticipated end date | 15/04/1992 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | All patients receive either a total mastectomy or tumour excision followed by radiotherapy. Eligible patients are randomised to receive: A. PRE-MENOPAUSAL PATIENTS 1. Regimen A: Chemotherapy, 5-fluorouracil, 4-epidoxorubicin and cyclophosphamide (FEC), repeated every 3 weeks for a total of eight cycles. 2. Regimen B: Chemotherapy, cyclophosphamide, methotrexate and 5-fluorouracil (CMF), repeated every 4 weeks for a total of six cycles. B. POST-MENOPAUSAL PATIENTS 3. Regimen C: Chemotherapy with FEC repeated every 3 weeks for a total of eight cycles. 4. Regimen D: No chemotherapy. |
| 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 | ISRCTN27799222 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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