Acceleration dating clinical trial
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That the substitution of CMF by Capecitabine will not be detrimental to patient outcome but will offer advantages in Quality of Life and/or toxicity.
Protocol TACT2: Version 1d approved on the 23/09/2005, UK Ethics Committee MREC ref: 04/MRE00/88Version 3 approved on the 13/05/2008.
As this new Regulation has not been finalised, its content is not widely discussed within this Toolkit at this stage.
Through the use of an interactive routemap, this site provides information on best practice and outlines the current legal and practical requirements for conducting clinical trials.This trial will take 4 dose escalated accelerated sequential chemo-radiotherapy schedules into a randomized phase II comparison with a UK standard sequential chemo-radiotherapy using state-of-the art radiotherapy.It would be impossible to test all schedules in phase III study so we will use a combined randomized phase II screening / " pick the winner " approach to select one schedule for further testing in a randomized phase III study.Histological diagnosis of invasive breast carcinoma2. Completely resected disease with negative surgical margins (apart from deep margin if full thickness resection).3. No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of pre-invasive or invasive cancer except:10.1 Previous radiotherapy for basal cell carcinoma 10.2 Previous pre-operative endocrine therapy provided that there was no evidence of progression during this therapy, that it was for less than 6 weeks in duration, and was stopped at least one month prior to trial entry11.Early stage disease (T0-3 N0-2 M0) with no evidence of distant metastases on routine staging4. No previous malignancy except in the case of DCIS, or basal cell carcinoma or cervical carcinoma in situ, or where the patient has been disease-free for 10 years, and where treatment consisted solely of resection.12.