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Recruiting NCT06830083

Hypofractionated Radiation Fractionation in Breast Cancer Patients with Implant-Based Reconstruction

Trial Parameters

Condition Breast Cancer
Sponsor The First Affiliated Hospital with Nanjing Medical University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 840
Sex FEMALE
Min Age 18 Years
Max Age 65 Years
Start Date 2025-01-30
Completion 2030-12-30
Interventions
Hypofractionated Radiation TherapyConventional fraction radiotherapy

Brief 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 Criteria

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

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