Health TrialsbyHealthPanel

Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction

ConditionsBreast CancerBreast ReconstructionRadiation Oncology
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female, aged 18-75 years

Karnofsky Performance Status ≥60

Histopathologically confirmed invasive breast adenocarcinoma

Total mastectomy [with or without nipple-areolar complex preservation] + axillary dissection/sentinel lymph node biopsy + implant/expander placement R0 resection with negative margins

Disqualifiers

Prior radiotherapy to chest wall or nodal regions

Pregnancy or lactation

T4 stage disease

Autologous breast reconstruction of the irradiated breast

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

506 Participants
are divided into 2 treatment groups
Group A: HFRT groupExperimental treatment 1 intervention
Group B: CFRT groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Reconstruction Failure Rate

implant removal, capsular contracture ≥ Baker grade III

Time frame
2 year

Secondary outcomes

1

Other Implant-Related Adverse Events

infection, skin necrosis, implant exposure

Time frame
2 year
2

Radiation-Related Toxicities

grade ≥3 dermatitis, pneumonitis, lymphedema

Time frame
2 year
3

DFS

Disease-Free Survival

Time frame
5 year
4

OS

Overall Survival

Time frame
5 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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