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IRCT20180919041070N1 IRCT 2019-04-04 Iran University of Medical Sciences Effect of radiotherapy time in breast cancer Comparison of the effectiveness of neoadjuvant with adjuvant radiotherapy in patients with early breast cancer 2019-01-21 anticipated 120 Complete https://irct.ir/trial/34516 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple randomization Random unit: Individual Randomization Tool: Random Number table. 3 breast cancer. Intervention 1: Intervention group: A group that received neoadjuvant radiation therapy (50 Gy in 25 fraction) and boost dose during surgery (12 Gy IORT)، then receive surgery, chemotherapy, and hormone therapy. Intervention 2: Intervention group: A group that received neoadjuvant radiation therapy (50 Gy in 25 fraction) and conventional boost dose (10 Gy in 5 fraction) , then receive surgery, chemotherapy, and hormone therapy. Intervention 3: Intervention group: A group that is undergoing surgery and chemotherapy, then receive adjuvant radiation therapy (50 Gy in 25 fraction) and boost dose during surgery (12 Gy IORT); then they receive hormone therapy. Intervention 4: Control group: A group that is undergoing surgery and chemotherapy, then receive adjuvant radiation therapy (50 Gy in 25 fraction) and conventional boost dose (10 Gy in 5 fraction); then they receive hormone therapy. Yes - There is a plan to make this available What will be shared: Individual data of the participants in the study: The total potential data after being unidentifiable is the sharing of individuals When: Access 1 year after the results are published To whom: For researchers working in academic and scientific institutions Conditions: If he want to do similar studies or meta-analysis and systematic review Where to obtain: Applicants can send their request to the following email address to receive the requested data Dr Mohaditha Shahin Shohaday-e-haftom-e-tir hospital, End of Shahid Rajaee Street, Shahr-e-Ray mohadese.shahin@gmail.com How to obtain: First, applicants send their request and proposal to following e-mail. after study it, data will be sent within 10 days. It should be noted that the applicant should be obliged to send me the result of his study immediately after the completion of the project. mohadese.shahin@gmail.com Comments:
public Pedram Fadavi
End of Shahid Rajaee Street, Shahr-e-Ray
Tehran Iran (Islamic Republic of) 1886718136 +98 21 5522 8580 Fadavi.p@iums.ac.ir Iran University of Medical Sciences scientific Nahid Nafisi
Rasoul Akram Hospital, Nayesh Street, Mansouri Street, Sattarkhan Street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 5001 Nafissi.n@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women with breast cancer with stage T1-T2 / N0 / M0, which have ER + and HER2-- Candidate for Radiation Therapy For the first time, they have had cancer age between 18 to 70 years 18 years 70 years Female Earlier history of radiation therapy C50 Malignant neoplasm of breast Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group: A group that received neoadjuvant radiation therapy (50 Gy in 25 fraction) and boost dose during surgery (12 Gy IORT)، then receive surgery, chemotherapy, and hormone therapy. Intervention group: A group that received neoadjuvant radiation therapy (50 Gy in 25 fraction) and conventional boost dose (10 Gy in 5 fraction) , then receive surgery, chemotherapy, and hormone therapy. Intervention group: A group that is undergoing surgery and chemotherapy, then receive adjuvant radiation therapy (50 Gy in 25 fraction) and boost dose during surgery (12 Gy IORT); then they receive hormone therapy. Control group: A group that is undergoing surgery and chemotherapy, then receive adjuvant radiation therapy (50 Gy in 25 fraction) and conventional boost dose (10 Gy in 5 fraction); then they receive hormone therapy. Cancer free survival. Timepoint: Every 3 months until two years. Method of measurement: absence of recurrence disease based on examination and ultrasound and mammography. Acute skin toxicity due to radiation therapy. Timepoint: Weekly evaluation during radiotherapy and then 4 and 12 weeks after radiotherapy. Method of measurement: Based on acute radiation dermatitis common toxicity criteria. Late skin toxicity due to radiation therapy. Timepoint: 6 months after radiotherapy and then every 3 months until one year. Method of measurement: Using the RTOG/EORTC radiation morbidity scoring scheme. Cosmetic results. Timepoint: Six months after radiotherapy and then every 6 months until 2 years. Method of measurement: RTOG (4 point scoring system), LENT-SOMA score and BCCT software. Surgical complications including infection, not wound healing & seroma. Timepoint: After two weeks of surgery. Method of measurement: History,inspection location of ulcer and examination, and ultrasound to estimate the amount of seruma. Iran University of Medical Sciences Approved 2018-12-22 Ethics committee of Iran University of Medical Sciences Fifth Floor, Central Headquarters, Iran University of Medical Sciences, Hemet Highway Between Chamran and Sheikh Fazlollah Tehran Tehran Iran (Islamic Republic of)