Hypofractionated Radiation Fractionation in Breast Cancer Patients with Implant-Based Reconstruction
The First Affiliated Hospital with Nanjing Medical University
840 participants
Jan 30, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- \. 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 Criteria6
- Auto-reconstruction surgery
- Clinical or pathological T4
- Both sides need radiotherapy
- Have a history of chest radiotherapy
- Pregnancy/lactation
- Participate in other drug clinical trials
Interventions
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 )
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06830083