Breast Cancer
Conditions
Keywords
implant-based reconstruction surgery, hypofraction radiation therapy
Brief summary
It is a randomized trial to assess the safety and efficacy between hypofractionation radiation and conventional radiation in women who have undergone mastectomy and immediate breast reconstruction. The investigators will evaluate reconstruction complication, radiotherapy side effects, cosmetic and oncologic outcomes.
Detailed description
Patients with breast cancer frequently have requirement for breast reconstruction after mastectomy. For patients with limited autologous tissue availability, implant-based reconstruction remains an effective alternative. Due to the absence of high-level evidence, collaborative efforts between surgical and radiation oncology teams are advised to determine the optimal sequencing and techniques for integrating reconstruction surgery with radiotherapy. The ongoing Alliance A221505 and FABREC phase III randomized controlled trials are comparing the incidence of reconstructive complications following hypofractionated and conventional fractionation radiotherapy. FABREC trial recently showed the hypofractionated regimen did not significantly improve change in physical well-being（PWB), domain of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality-of-life assessment tool, compared with the conventional fractionation radiotherapy. This trial added to the increasing experience with HF PMRT in patients with implant-based reconstruction. In 2019, the European Society for Radiotherapy and Oncology (ESTRO) provided guidelines for target delineation based on the position of the implant in breast reconstruction to minimize the irradiation of normal tissues. Existing studies on the risk of complications from irradiating expanders and implants have yielded inconsistent conclusions, with each approach having its own advantages and disadvantages. Our study aims to compare the incidence of reconstructive complications between hypofractionated and conventional fractionation radiotherapy after implant-based reconstruction surgery to provide high-level evidence for medium-dose hypofractionated radiotherapy after immediate implant-based reconstructive surgery.
Interventions
RADIATIONHypofractionated Radiation Therapy
Hypofractionation regimen: Total dose to the chest wall and the regional lymph nodes is 4050 cGy, and each fraction consists of 270 cGy per day(daily, Monday through Friday )
RADIATIONConventional fraction radiotherapy
Total dose of plan tumor volume is 5000 cGy，and each fraction will consist of 200 cGy per day. 25 fractions(daily, Monday through Friday) to the chest wall and to the supraclavicular (with or without axillary) lymph nodes.
Sponsors
Jiangsu Taizhou People's Hospital
Hunan Cancer Hospital
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1\. Pathological diagnosis of stage I-III breast cancer (non-T4), \>18 years old; 2. Complete breast cancer resection (including skin-sparing and nipple-sparing total resection) 3. According to the guidelines of the Chinese Anticancer Society, postoperative adjuvant radiotherapy is required; 4. Undergo immediate reconstructive surgery (tissue dilator or permanent implant)
Exclusion criteria
1. Auto-reconstruction surgery 2. Clinical or pathological T4 3. Both sides need radiotherapy 4. Have a history of chest radiotherapy 5. Pregnancy/lactation 6. Participate in other drug clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major complication | From enrollment to the end of treatment at 24 months | implant related complications requiring reoperation such as severe necrosis，severe infections, severe capsular contracture, implant rupture and implant exposure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any breast-related complications | From enrollment to the end of treatment at 24 months | Complications included infections, wound dehiscence, skin flap necrosis, implant exposure, capsular contracture, seroma, and hematoma. |
| Absolute reconstruction failure | From enrollment to the end of treatment at 24 months | — |
| Oncologic outcomes | From enrollment to the end of treatment at 5 years | local-regional recurrence free survival |
| Cosmetic outcomes | From enrollment to the end of treatment at 24 months | satisfaction with breast and physical and psychosocial well-bing after radiotherapy will be assessed from baseline to 24 months by trained physicians using Breast-Q Version 2.0© Reconstruction Module Scales Chinese (CN) Version . |
Countries
China
Contacts
Primary ContactJiangsu Province People's Hospital
Outcome results
None listed