Hypofractionated Radiation Therapy: Hypofractionation regimen: Total dose to the chest wall and the regional lymph nodes is 4050 cGy, and each fraction consists of 270 cGy per day(daily, Monday through Friday )
Conventional fraction radiotherapy: Total dose of plan tumor volume is 5000 cGy，and each fraction will consist of 200 cGy per day. 25 fractions(daily, Monday through Friday) to the chest wall and to the supraclavicular (with or without axillary) lymph nodes.
Study summary
It is a randomized trial to assess the safety and efficacy between hypofractionation radiation and conventional radiation in women who have undergone mastectomy and immediate breast reconstruction. The investigators will evaluate reconstruction complication, radiotherapy side effects, cosmetic and oncologic outcomes.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1\. Pathological diagnosis of stage I-III breast cancer (non-T4), \>18 years old; 2. Complete breast cancer resection (including skin-sparing and nipple-sparing total resection) 3. According to the guidelines of the Chinese Anticancer Society, postoperative adjuvant radiotherapy is required; 4. Undergo immediate reconstructive surgery (tissue dilator or permanent implant)
Exclusion Criteria:
1. Auto-reconstruction surgery
2. Clinical or pathological T4
3. Both sides need radiotherapy
4. Have a history of chest radiotherapy
5. Pregnancy/lactation
6. Participate in other drug clinical trials
Primary outcome measure(s)
Major complication — From enrollment to the end of treatment at 24 months implant related complications requiring reoperation such as severe necrosis，severe infections, severe capsular contracture, implant rupture and implant exposure.
Trial sites (1)
Facility
City
Region
Status
Jiangsu Province People's Hospital/The First Affiliated with Nanjing Medical University
Nanjing
Jiangsu
Recruiting
More The First Affiliated Hospital with Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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