Hypofractionated Radiation Fractionation in Breast Cancer Patients With Implant-Based Reconstruction
Recruiting · NCT06830083 · Interventional (participants receive a specific treatment) · Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
View the official record on ClinicalTrials.gov →Interventions studied
Conventional fraction radiotherapyHypofractionated Radiation Therapy
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- \. 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
- 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
Where it is running
1 location listed.
- Jiangsu Province People's Hospital/The First Affiliated with Nanjing Medical University - Nanjing, Jiangsu, China