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Trial Title:
Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
NCT ID:
NCT05992870
Condition:
Breast Cancer
Implant Breast Reconstruction
Neoadjuvant Radiotherapy
Conditions: Keywords:
neoadjuvant radiotherapy, implant, breast reconstruction
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Neoadjuvant radiotherapy
Description:
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.
Arm group label:
Neoadjuvant radiotherapy group
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xinhong Wu
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinhong Wu, MD
Phone:
+8618602726300
Email:
34053889@qq.com
Contact backup:
Last name:
Ning Zou, MD
Phone:
+8615007162698
Email:
sunnyning116@163.com
Start date:
July 8, 2023
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Hubei Cancer Hospital
Agency class:
Other
Source:
Hubei Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05992870
