Effect of radiotherapy time in breast cancer

Phase 3

Recruiting

• Conditions: Malignant neoplasm of breast; breast cancer.

• Registration Number: IRCT20180919041070N1
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 23 April 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

Earlier history of radiation therapy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.