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Brief Title: A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer.
Official Title: An International Randomised Controlled Trial to Compare Targeted Intra-operative Radiotherapy Boost With Conventional External Beam Radiotherapy Boost After Lumpectomy for Breast Cancer in Women With a High Risk of Local Recurrence.
Study ID: NCT01792726
Brief Summary: TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial in which each participating centre can use the local predefined inclusion/exclusion criteria for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are eligible to enter patients into the trial. Eligible patients are those with a higher risk of local recurrence after breast conserving surgery. After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All patients will receive whole breast EBRT. They may receive any other adjuvant treatments as deemed necessary. The protocol recommends that patients be followed at six monthly intervals for three years and then annually. The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are relapse-free survival, site of recurrence, overall survival (breast-cancer specific and non-breast cancer deaths) patient satisfaction and quality of life.
Detailed Description: DESIGN: A pragmatic multi-centre randomised clinical trial to test whether TARGeted Intraoperative radioTherapy as a tumour bed Boost (TARGIT-B) is superior in terms of local relapse within the treated breast compared with standard post-operative external beam radiotherapy boost in women undergoing breast conserving therapy who have a higher risk of local recurrence. Patients can be entered before the primary surgery or in a smaller proportion of cases, post-pathology. SETTING: Specialist breast units in UK, USA, Canada, Australia and Europe; 31 centres currently recruiting in the TARGIT-A trial and several are ready to join. TARGET POPULATION: Breast cancer patients suitable for breast conserving surgery, but with a high risk of local recurrence. Details of inclusion and exclusion are given in part 2. Briefly the patients should be either younger than 45 or if older, need to have certain pathological features that confer a high risk of local recurrence of breast cancer. HEALTH TECHNOLOGIES BEING ASSESSED. The TARGIT Technique: The Intrabeam® (Carl Zeiss, FDA approved and CE marked) is a miniature electron beam-driven source which provides a point source of low energy X-rays (50kV maximum) at the tip of a 3.2mm diameter tube. The radiation source is inserted into the tumour bed immediately after excision of the tumour and switched on for 20-35 minutes to provide intra-operative radiotherapy accurately targeted to the tissues that are at highest risk of local recurrence. The physics, dosimetry and early clinical applications of this soft x-ray device have been well studied. For use in the breast, the technique was first developed and piloted at University College London. The radiation source is surrounded by a spherical applicator, specially designed (and available in various sizes) to produce a uniform field of radiation at its surface, enabling delivery of an accurately calculated dose to a prescribed depth. It is inserted in the tumour bed and apposed to it with surgical sutures and/or other means. As the x-rays rapidly attenuate the dose to more distant tissues is reduced; this also allows it to be used in standard operating theatres. 20 Gy is delivered to the tumour bed surface in 20-35 minutes, after which the radiation is switched off, the applicator removed, and the wound closed in the normal way. This simple technique has potentially several advantages over convential external beam radiotherapy, interstitial implantation of radioactive wires or conformal external beam radiotherapy. The first pilot of twenty-five cases was at performed at UCL using TARGIT technique as a replacement for the boost dose of radiotherapy; full dose external beam treatment was subsequently given. The phase II study of 300 patients was published and recently updated with long term data along with favourable toxicity and cosmetic outcome results of individual cohorts. A mathematical model of TARGIT developed recently (funded by Cancer Research UK) suggests that it could be superior to conventional radiotherapy. Translational research has found that TARGIT impairs the surgical-trauma-stimulated proliferation and invasiveness of breast cancer cells. This effect of radiotherapy may act synergistically with its tumouricidal effect yielding a superior result. MEASUREMENT OF COST AND OUTCOME: Patient assessments will be clinical examination (6 monthly x 3 years then yearly x 10 years) and mammography (yearly). with ulstrasound (if needed) . Primary outcome: histologically/cytologically proven local recurrence. Secondary: site of relapse in the breast, overall survival, local toxicity (RTOG and LENT SOMA criteria), cosmesis, quality of life, patient satisfaction and health economics. The cost and cost-effectiveness of TARGIT versus EBRT, both as boost, will be calculated from a NHS and personal social services (PSS) perspective. Costs directly incurred by patients will also be assesed, since EBRT as a boost is likely to impose additional time and travel expense to patients and families.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Helen Rey Breast Cancer Research Foundation, Los Angeles, California, United States
Memorial Health University Medical Center, Savannah, Georgia, United States
Beaumont Health - Royal Oak, Detroit, Michigan, United States
Lakeland Regional Health System, Saint Joseph, Michigan, United States
Ashikari Breast Center, Dobbs Ferry, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
West Virginia University, Morgantown, West Virginia, United States
Aurora Breast Center, Green Bay, Wisconsin, United States
Beijing Cancer Hospital, Beijing, , China
Institut Bergonié, Bordeaux, , France
Centre François Baclesse, Caen, , France
Centre Georges François Leclerc, Dijon, , France
Centre Léon Bérard, Lyon, , France
Hôpital Nord, Marseille, , France
Institut de Cancerologie de l'Ouest site René Gauducheau, Nantes, , France
Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse, , France
Centro Di Riferimento Oncologico Di Aviano, Aviano, , Italy
Istituto Oncologico Veneto, Padova, , Italy
Gangnam Severance Hospital, Seoul, , Korea, Republic of
University Malaya Medical Centre, Kuala Lumpur, , Malaysia
University of Dammam, Dammam, , Saudi Arabia
Netcare Milpark Hospital, Johannesburg, , South Africa
Institut Català d'Oncologia, Barcelona, , Spain
Hospital Universitario Dr Negrín, Las Palmas de Gran Canaria, , Spain
Brust-Zentrum Onkologie, Zürich, , Switzerland
Queen Sirikit Cantre for Breast Cancer, Bangkok, , Thailand
Princess Alexandra Hospital NHS Trust, Harlow, , United Kingdom
Whittington Hospital, London, , United Kingdom
Royal Free London NHS Trust, London, , United Kingdom
Guy's Hospital, London, , United Kingdom
Hospital of St John and St Elizabeth, London, , United Kingdom
Princess Grace Hospital, London, , United Kingdom
The Great Western Hospital, Swindon, , United Kingdom
Hampshire Hospitals NHS Foundation Trust, Winchester, , United Kingdom
Name: Jayant S Vaidya, MBBS FRCS
Affiliation: University College, London
Role: PRINCIPAL_INVESTIGATOR