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| SEquencing of Chemotherapy and Radiotherapy in Adjuvant Breast cancer |
| Source of record | UK Trials |
| ISRCTN | ISRCTN84214355 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | BR3015 |
| Public title | SEquencing of Chemotherapy and Radiotherapy in Adjuvant Breast cancer |
| Scientific title | |
| Acronym | SECRAB |
| Disease/condition/study domain | Breast cancer |
| Study hypothesis | To answer reliably two questions in the timing of delivery of chemotherapy and radiotherapy in the adjuvant treatment of early breast cancer: 1. Can local control be improved by synchronous delivery of adjuvant chemotherapy and radiotherapy thereby not delaying the administration of either modality? 2. Can synchronous chemotherapy and radiotherapy be given safely without significant enhancement of acute or late toxicity, without compromising on dose intensity of either modality and without adversely affecting quality of life or cosmesis? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | No ethics approval information required at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histological diagnosis of invasive breast carcinoma (unilateral if participating in the Cosmesis Study) 2. Wide local excision or mastectomy with macroscopic complete excision of clinically early stage disease and no evidence of metastases 3. There is a clear indication for both adjuvant chemotherapy and radiotherapy, or the patient has been randomised to these treatments in another study 4. The intended schedules can be given synchronously and the patient is considered suitable to receive either treatment sequence 5. Medically fit enough to complete chemotherapy and radiotherapy, with adequate cardiac, renal, hepatic and bone marrow function 6. The patient has given written informed consent 7. No prior chemotherapy (other than hormone manipulation) 8. No prior malignancy (except skin basal/squamous cell or in situ carcinoma) 9. Not currently pregnant or lactating, no intention of pregnancy during treatment 10. No other medical or social contra-indication to entry and follow-up |
| Participants - exclusion criteria | N/A |
| Patient information material | |
| Anticipated start date | 02/07/1998 |
| Anticipated end date | 25/03/2004 |
| Status of trial | Completed |
| Target number of participants | 2298 |
| Interventions | Two arms: Arm 1 - Synchronous treatment (Chemotherapy - Radiotherapy - Chemotherapy) Arm 2 - Sequential Treatment (Chemotherapy - Radiotherapy) |
| Primary outcome measure(s) | Local tumour recurrence rates at five and ten years |
| Secondary outcome measure(s) | 1. Distant and overall recurrence rates 2. Survival at five, ten and 15 years 3. Acute toxicity causing significant treatment delay or dose reduction 4. Other late effects of treatment |
| Sources of funding | Cancer Research UK (UK) |
| Sponsor name | University Hospitals Birmingham NHS Foundation Trust (UK) |
| Sponsor details | Research & Development Nuffield House Queen Elizabeth Hospital Edgbaston Birmingham United Kingdom B15 2TH |
| Sponsor telephone | +44 (0)121 697 8311 |
| Sponsor fax | +44 (0)121 697 8310 |
| Contact name | Dr Sarah Bowden |
| Contact details | CRUK Clinical Trials Unit Institute for Cancer Studies The University of Birmingham Edgbaston Birmingham United Kingdom B15 2TT |
| Contact telephone | +44 (0)121 414 4371 |
| Contact fax | +44 (0)121 414 3700 |
| Contact email | BTT@bham.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN84214355 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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