Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age19-85
SponsorSeoul National University Bundang Hospital
About this trial
This randomized Phase III study aims to show major complication rate of hypofractionation radiation therapy is not inferior, compared to conventional fractionation radiation therapy in breast cancer patients undergoing mastectomy and reconstruction surgery.
Eligibility criteria
Qualifiers
Female patient who underwent mastectomy for invasive breast cancer
Patients who have undergone breast reconstruction after mastectomy or who have inserted a tissue expander
(y)p patients with stage IIIA or lower (excluding T4 and N3 patients) who need adjuvant radiation therapy
Eastern Cooperative Oncology Group Performance ≤ 2
Disqualifiers
Patients who already had implants at the time of diagnosis of breast cancer or who have already undergone reconstructive surgery
Patients who underwent reconstruction after partial resection or breast conserving surgery rather than mastectomy
Patients who are using or planning to use an air expander
Patients receiving radiation therapy for salvage or palliative purposes
Trial design
Treatments tested in this trial
- Hypofractionation
- Conventional Fractionation
Treatment groups
622 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Seoul National University Bundang Hospital
Lead sponsor
Seoul National University Hospital
Collaborator
Source ClinicalTrials.gov