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

Recruiting now · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT06830083

Run by

The First Affiliated Hospital with Nanjing Medical University

People needed

840

Starts

2025-01-30

Expected to finish

2033-12-01

Last updated by the study team

2025-02-17

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

• Jiangsu Province People's Hospital/The First Affiliated with Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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