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IRCT20201106049287N1 IRCT 2021-12-14 Tehran University of Medical Sciences Evaluation of early toxicity of daily and weekly concomitant boost in comparison with conventional boost in early stage breast cancer patients treated with hypofractionated Radiotherapy in 2019-2020 at Cancer Institute of Tehran Evaluation of early toxicity of daily and weekly concomitant boost in comparison with conventional boost in early stage breast cancer patients treated with hypofractionated Radiotherapy in 2019-2020 at Cancer Institute of Tehran 2019-09-23 anticipated 90 Complete https://irct.ir/trial/52618 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be determined by random blocking method with 4 blocks and using the table of random numbers by Random Allocation Software. Random assignment to intervention and control groups, description of how to block and allocation sequence for concealment will be done by the person not involved in the research (Allocation Concealment). The allocation ratio of the samples will be (Allocation 1: 1: 1). Patients will be divided into 3 groups receiving Boost radiation therapy weekly, daily and control (Assignment). Then, based on the obtained blocks and in the order of allocation, patients will be treated. This study is Open-Label and will not be blinded. 3 Radiotherpy in Breast Cancer. Intervention 1: Intervention group: daily concurrent RT boost. In the concomitant boost group, a total dose of 8 grey will be treated with 50 c-grey daily with basic radiotherapy. Intervention 2: Intervention group: weekly RT boost. In the weekly concomitant boost group, a total dose of 9 grey in 3 sessions on Thursdays of each week will be treated with a dose of 3 grey in each session. Yes - There is a plan to make this available What will be shared: Charctristics of patients based on age, TNM staging, hormone receptor, quality and quantity of toxicities and cosmetic results When: Between 6 months or 1 year after publication To whom: Just researchers at university or scientific organizations Conditions: Not pre spcified Where to obtain: Email the writer Naeim_nabian2@yahoo.com How to obtain: The applicant must have submitted their identity information or that of the company in question. Also, the analyzes that are to be done on the data must be sent in advance. And after about 1-3 months, the result of the request will be announced. Comments:
public Naeim Nabian
Imam khomeini Hospital, Blv Keshavarz
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2834 naeim_nabian2@yahoo.com Tehran University of Medical Sciences scientific Naeim Nabian
Imam khomeini Hospital, Blv Keshavarz
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2834 naeim_nabian2@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Female Older than 18 Stage 1 or 2 Breast conservating surgery Negative margin Negative lymph node 18 years no limit Female positive LN at axillary dissection Multifocal tumour Paget’s disease pathological skin involvement, synchronous or previous breast cancer, other malignant disease, pregnant or lactating patient Previous irradiation to ipsilateral breast or thorax C50 Malignant neoplasm of breast Treatment - Other Treatment - Other Intervention group: daily concurrent RT boost. In the concomitant boost group, a total dose of 8 grey will be treated with 50 c-grey daily with basic radiotherapy. Intervention group: weekly RT boost. In the weekly concomitant boost group, a total dose of 9 grey in 3 sessions on Thursdays of each week will be treated with a dose of 3 grey in each session. Skin Reactin. Timepoint: After Radiotherapy, 1 month later, every 3 months up to 1 year. Method of measurement: Use NCI CTCAE version 3.0 toxicity criteria and rates of acute toxicity. Cosmetic result. Timepoint: 3 months. Method of measurement: Comparison with healthy opposite breasts in size, indentation, shape and symmetry. Tehran University of Medical Sciences Approved 2019-11-27 Ethics committe of Emam Khomeini Hospital Complex of Tehran University of Medical Science Keshavarz Blvd, Dr.Gharib Street Tehran Tehran Iran (Islamic Republic of)