Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Location status: Recruiting
NCT Number: NCT07835139
This is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based breast reconstruction. The primary objective is to evaluate whether hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy regarding the rate of unplanned reoperation.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Shanghai, 200032, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
50Gy/25Fx, 2Gy/Fx, once daily
42.56Gy/16Fx, 2.66Gy/Fx, once daily
Time frame: 3 years
Surgery performed to treat complications related to breast reconstruction.
Time frame: 3 years
Defined as adverse events following implant-based breast reconstruction, including reconstruction-related surgical complications and implant-specific complications.
Time frame: 5 years
Locoregional recurrence is defined as the first documented recurrence in the ipsilateral chest wall or regional nodes.
Time frame: 5 years
Distant metastasis is the first confirmed recurrence in any distant organ/site beyond the ipsilateral chest wall and regional nodes.
Time frame: 5 years
Overall survival is the time from randomization to death from any cause.
Interested in participating?
Request InfoFudan University
Other
Outcomes of Hypofractionated Versus Conventionally Fractionated Radiotherapy After Mastectomy and Implant-Based Reconstruction: A Prospective, Randomized Controlled, Non-Inferiority Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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