RecruitingNot ApplicableNCT05992870

Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction


Sponsor

Hubei Cancer Hospital

Enrollment

40 participants

Start Date

Jul 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Neoadjuvant radiotherapy(NART) followed by mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. However, reports of NACT followed immediate implant-based breast reconstruction are rare. Some studies have shown that NART followed immediate implant-based breast reconstruction seems feasible and can be safely attempted. It's well known that radiotherapy after implant-based breast reconstruction have negative effects on implant and cosmetic results. So, investigators conducted a polit study to learn about acute post-surgical complications following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether radiation therapy can be given before mastectomy (breast removal surgery) instead of after, and whether this timing is safe when combined with breast reconstruction using an implant placed at the same time as the surgery. **You may be eligible if...** - You are a woman over 18 years old - You have been diagnosed with breast cancer confirmed by a biopsy - You need to have a mastectomy - You are expected to need radiation therapy - You plan to have breast reconstruction using an implant **You may NOT be eligible if...** - You have had a previous breast cancer or another cancer that required breast/underarm radiation - You are unable to give informed consent - Your medical team cannot determine whether radiation is needed before surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONNeoadjuvant radiotherapy

In case of neoadjuvant chemotherapy, RT will start 3-4 weeks after the last course of chemotherapy. A dose of 15 x 2.67 Gy 5 fractions or 16 x 2.67Gy 5 fractions per week. A skin-sparing mastectomy and a immediate implant-based breast reconstruction will be performed, approximately 2-6 weeks after latest radiotherapy treatment.


Locations(1)

Xinhong Wu

Wuhan, Hubei, China

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NCT05992870


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