Status:
NOT_YET_RECRUITING
Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborating Sponsors:
Seoul National University Hospital
Conditions:
Breast Cancer
Radiotherapy; Complications
Eligibility:
FEMALE
19-85 years
Phase:
PHASE3
Brief Summary
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 p...
Detailed Description
This study is a multicenter, randomized, phase 3 clinical trial. For breast cancer patients who underwent breast reconstruction after mastectomy, the hypofractionation radiotherapy group (experimental...
Eligibility Criteria
Inclusion
- 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
- Age ≥ 19 years
- Patients who agreed to participate in the study
Exclusion
- 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
- Patients with distant metastases at the time of diagnosis
- Patients who are scheduled to undergo concurrent chemoradiation therapy
- Patients with bilateral breast cancer
- Male breast cancer patients
- Patients who have previously received radiation therapy for the ipsilateral breast or supraclavicular area
- Patients with history of cancers other than thyroid cancer, intraepithelial cancer of the cervix, or skin cancer
- Patients diagnosed with ductal breast carcinoma in situ, lobular carcinoma in situ, phyllodes, metaplastic cancer, or other benign tumors based on histological diagnosis
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
622 Patients enrolled
Trial Details
Trial ID
NCT05253170
Start Date
April 1 2022
End Date
December 31 2032
Last Update
March 11 2022
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