MedTrace Logo

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

NCT06830083 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 840

Last updated 2025-02-17

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Hypofractionated Radiation Therapy

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 )

RADIATION

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 supraclavicular (with or without axillary) lymph nodes.

Sponsors & Collaborators

  • Jiangsu Taizhou People's Hospital

    collaborator OTHER

  • Hunan Cancer Hospital

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-30
Primary Completion
2030-12-30
Completion
2033-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06830083 on ClinicalTrials.gov