Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Hubei Cancer Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Postoperative complications at 3 months following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
Radiotherapy after implant-based breast reconstruction have negative effects on implant and cosmetic results, including severe capsular contracture, mastectomy flap necrosis ,reoperation and so on. Postmastectomy radiotherapy( PMRT )is associated with implant reconstruction failure. PRADA study has shown neoadjuvant radiotherapy followed by skin-sparing mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. The investigators assume that neoadjuvant radiotherapy can avoid the negative effects of PMRT on an implant and the capsule of an implant and would lead to better cosmetic results and less complications compared to PMRT. Furthermore, some studies have shown that NART could potentially result in shorter time between diagnosis and treatment completion. 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.
Investigators
Xinhong Wu, PhD
vice-president
Hubei Cancer Hospital
Eligibility Criteria
Inclusion Criteria
- •Women \>18 years with histopathologically-confirmed breast cancer, who:
- •require mastectomy for any reason
- •a known indication for (adjuvant) radiotherapy
- •require implant-based breast reconstruction
Exclusion Criteria
- •Inability to give informed consent
- •MDT unable to make recommendation for radiotherapy based on pre-operative histopathological and imaging findings
- •Previous history of breast cancer or another malignancy for which radiotherapy of the breast or axilla
- •Pregnant or lactating
- •inflammatory breast cancer
Outcomes
Primary Outcomes
Postoperative complications at 3 months following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART
Time Frame: 3 months following skin-sparing mastectomy and immediate breast reconstruction
Surgical complications are defined as any complication requiring surgical intervention necessary within a period up to three months after the final reconstruction. Including Infection, hematoma , loss of implant or flap, fat necrosis, wound breakdown,defined and scored using the C-DC37.
Secondary Outcomes
- Patient satisfaction.(3 months and 12 months after surgery)
- Number of participants with removal of implant.(6 months after surgery)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 .(Within 3 months after both breast reconstruction and radiotherapy)
- Pathological complete response (pCR) assessed in skin-sparing mastectomy specimen(Within 2 weeks after skin-sparing mastectomy)