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Impact of Tumor Bed Localisation on Dosimetry Boost Irradiation in Patients Undergoing Breast Conserving Surgery

Tata Memorial Centre · 2017
ClinicalTrials.gov · Datasets · License: Public Domain · 2017
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breast-carcinoma
PRIMARY STUDY OBJECTIVES: To evaluate dosimetric outcomes in tumor bed boost irradiation in patients undergoing breast conservative surgery using three different surgical techniques SECONDARY OBJECTIVES- Evaluation of cosmesis in patients prior to radiotherapy, at the time of completion of radiotherapy and 6 months post completion of radiotherapy STUDY DESIGN: Three arm, Prospective Observational Trial TREATMENT REGIMEN: Group A- Patients who underwent open cavity Breast Conservative surgery(BCS) Group B- Patients who underwent closed cavity BCS Group C- Patients who underwent oncoplasty All patients will first receive external beam Radiotherapy to the whole breast to a dose of 40 Grays /15#/3 weeks. The patients will then be planned for boost radiation to the tumor bed to a dose of 12.5 Grays/5#. RECRUITMENT TARGET: 20 Patients The sample size has not been calculated as this is a pilot study. Twenty patients will be accrued for the purpose of this study PRIMARY ENDPOINT 1. Dosimetric Measurement * Seroma cavity volume (ccs). * PTV volume (ccs). * Ratio between the PTV volumes to the whole breast volume * Radiation Conformity Index (RCI) * Dose Homogeneity Index (DHI) * Ratio of dose received by 95% of PTV volume to the dose received by 5% of PTV volume * Dose received by several normal structures; normal ipsilateral breast tissue, contralateral breast, ipsilateral lung, contralateral lung, and heart 2. Cosmesis Measurement * prior to starting radiotherapy, * at the time of conclusion of radiotherapy * 6 months post completion of radiotherapy
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