Hypofractionated Radiation Fractionation in Breast Cancer Patients with Implant-Based Reconstruction
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
China
Jiangsu Province People's Hospital/The First Affiliated with Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Jiangsu Province People's Hospital
13770662828@163.com
86-025-68307676
Time Frame
Start Date: 2025-01-30
Estimated Completion Date: 2033-12
Participants
Target number of participants: 840
Treatments
Active_comparator: 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 regional (with or without axillary) lymph nodes.
Experimental: hypofractioned radiotherapy
Total dose of plan tumor volume is 4050 cGy，and each fraction will consist of 270 cGy per day. 15 fractions(daily, Monday through Friday) to the chest wall and to the regional (with or without axillary) lymph nodes.
Related Therapeutic Areas
Sponsors
Collaborators: Hunan Cancer Hospital, Jiangsu Taizhou People's Hospital
Leads: The First Affiliated Hospital with Nanjing Medical University