Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorHubei Cancer Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
require mastectomy for any reason
a known indication for (adjuvant) radiotherapy
require implant-based breast reconstruction
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Neoadjuvant radiotherapy
RadiationIn 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Neoadjuvant radiotherapy groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative complications at 3 months following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART
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.
Time frame
3 months following skin-sparing mastectomy and immediate breast reconstructionSecondary outcomes
1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 .
Other adverse events following NART or surgery other than described in the primary outcome measure.
Time frame
Within 3 months after both breast reconstruction and radiotherapy2
Number of participants with removal of implant.
Implant are removed for postoperative complications.
Time frame
6 months after surgery3
Patient satisfaction.
Patient satisfaction (as measured using the BREAST-Q reconstruction module) before, 3 months after, and 12 months after surgery.
Time frame
3 months and 12 months after surgery4
Pathological complete response (pCR) assessed in skin-sparing mastectomy specimen
A pCR was defined as absence of invasive and in situ carcinoma in the breast, irrespective of nodal status (ypT0).
Time frame
Within 2 weeks after skin-sparing mastectomySponsors and contacts
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Source ClinicalTrials.gov