Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT07084519
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • hypofractionated radiotherapy — RADIATION
    43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks)
  • conventional fractionated radiotherapy — RADIATION
    50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks

Study Details

This study investigates the safety and efficacy of hypofractionated radiotherapy (HFRT) versus conventional fractionated radiotherapy (CFRT) in breast cancer patients undergoing total mastectomy with prosthetic reconstruction. Study Design Population: Patients with high-risk breast cancer after mastectomy and immediate implant reconstruction. Intervention: HFRT Arm: 43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks). Control Arm: CFRT (50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks). Endpoints Primary: Reconstruction failure rate (e.g., implant removal, capsular contracture)

Key Dates

First listed
Jul 24, 2025
Start date
Mar 27, 2026
Status verified
Jun 2025
Primary completion
Mar 27, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
506 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HFRT group
    43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks)
  • Other: CFRT group
    50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks

Primary Outcome Measure

Reconstruction Failure Rate [ Time Frame: 2 year ]

Central Contacts

Related Studies