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Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy
Sponsor: Danish Breast Cancer Cooperative Group
Summary
In breast cancer patients treated by mastectomy and adjuvant post-mastectomy radiation therapy (PMRT) reconstruction is often delayed until 6 - 12 month after completion of chemotherapy and PMRT, due to high risk of complication. In this trial the safety of the delayed-immediate reconstruction method is tested, where a skin sparing mastectomy and reconstruction with silicone implant is performed at primary surgery to save the native skin for the final delayed reconstruction.
Official title: The DBCG RT Recon Trial: Delayed-immediate Versus Delayed Breast Reconstruction in Early Breast Cancer Patients Treated With Mastectomy and Adjuvant Loco-regional Radiation Therapy. A Multicenter Randomized and Single Arm Clinical Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
590
Start Date
2020-01-01
Completion Date
2035-11
Last Updated
2025-02-06
Healthy Volunteers
No
Interventions
Delayed-immediate reconstruction
Skin sparing mastectomy and reconstruction with silicone implant or expander covered by pectoral muscle and mesh or matrix. Final reconstruction with any reconstructive procedure 6-12 months after completion of chemotherapy and RT.
Delayed reconstruction
Total mastectomy and delayed reconstruction:with any reconstructive procedure 6-12 months after completion of PMRT
Locations (8)
Åbenrå Sygehus
Aabenraa, Denmark
Ålborg Universitetshospital
Aalborg, Denmark
Århus Universitets Hospital
Aarhus, Denmark
Gentofte Hospital/Herlev Hospital
Copenhagen, Denmark
Esbjerg Sygehus
Esbjerg, Denmark
Sjællands Universitetshospital
Roskilde, Denmark
Vejle Sygehus
Vejle, Denmark
Viborg Sygehus
Viborg, Denmark