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| Adjuvant Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) versus 5-Fluorouracil, Epirubicin and Cyclosphosphamide (FEC) in Node Negative Poor-Risk Primary Breast Cancer |
| Source of record | UK Trials |
| ISRCTN | ISRCTN81164554 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | ICCG/6/89 |
| Public title | Adjuvant Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) versus 5-Fluorouracil, Epirubicin and Cyclosphosphamide (FEC) in Node Negative Poor-Risk Primary Breast Cancer |
| Scientific title | |
| Acronym | Not Applicable |
| 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. Histologically proven invasive adenocarcinoma axillary nodes must be histologically negative 3. Tumour is T1c to T3 4. Tumour shows one of the following features of poor prognosis: a) Estrogen receptor less than or equal to 10 fmol/mg cytosol protein b) Grade III c) Vessel invasive d) High labelling index of S phase e) Aneuploidy f) Tumour size at least 2 cm 5. Adequate renal, hepatic and haematological function 6. No evidence of metastatic disease 7. No evidence of inflammatory carcinoma 8. Patients with bilateral malignancy or with a mass in the opposite breast, unless there is biopsy proof that it is not a malignancy, are excluded 9. Patients with findings that relate them to a category of more advanced disease are not eligible 10. Patients with clinically positive nodes in the axilla opposite the affected breast, or with palpable supraclavicular or infraclavicular nodes are considered ineligible unless there is a biopsy evidence that these are not involved with the tumour 11. No previous or concomitant malignancy, except squamous or basal cell carcinoma which has been effectively treated and carcinoma in situ of the cervix which has been treated operatively 12. No prior therapy for the present breast cancer including radiotherapy, chemotherapy, immunotherapy and/or hormonal therapy 13. No non-malignant systemic disease which would preclude their being subjected to any of the treatment options or prevent prolonged follow up 14. No active or previous cardiac disease that would preclude the use of 4-epidoxorubicin 12. No psychiatric or addictive disorders which should preclude obtaining informed consent |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material | |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients randomised to receive chemotherapy will receive CMF or FEC no sooner than 2 weeks and no later than 4 weeks following primary surgery. Patients will receive either: 1. CMF Regimen: Chemotherapy, CMF (cyclophosphamide, methotrexate, 5-fluorouracil) repeated every 4 weeks for six cycles. 2. FEC Regimen: Chemotherapy, FEC (5-fluouracil, 4-epidoxorubicin, cyclophosphamide) repeated every 4 weeks for 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 |
| 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 | ISRCTN81164554 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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