Partial Chest Wall Radiation Therapy After Total/Skin Sparing Mastectomy and Immediate Implant-based Reconstruction for Breast Cancer Patients at Increased Risk of Local Recurrence
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 主要终点
- Assess feasibility , defined as patient set-up reproducibility, plan reproducibility through in vivo dosimetry and dosimetrical reduction of PCWRT vs. conventional chest wall radiotherapy
研究概览
简要总结
STUDY DESCRIPTION: This is a single-arm study to assess the feasibility, toxicity and cosmetic outcome of partial radiotherapy of the chest wall in breast cancer patients at increased risk of local relapse submitted to nipple-areola complex (NAC) sparing mastectomy and immediate implant-based reconstruction Inclusion criteria
Histologically confirmed diagnosis of in situ ductal carcinoma (pTis) or invasive breast carcinoma (pT1 and pT2), submitted to NAC sparing mastectomy with prosthetic-based breast reconstruction (expander or prosthesis) and:
Group A)
Negative sentinel node dissection or axillary clearance (pN0) and all the following risk factors:
Close (less than 1 mm) or positive (ink on tumor margin) surgical margin in a single breast quadrant Tumor diameter >2 cm Age ≤50 years Group B)
Positive sentinel dissection (pN1a) followed by axillary clearance (or primary axillary clearance) with only 1 positive node and any of the following risk factors:
Close (less than 1 mm) or positive (ink on tumor margin) surgical margin in a single breast quadrant Age ≤50 years Tumor diameter >2 cm Grade 3 histology Lymphovascular invasion HER-2 overexpression/amplification Triple negativity Treatment - Radioterapy The tumor bed is defined by the area at risk (skin and the pectoralis muscles) delineated by surgical clips and 3D-MRI reconstruction for a precise localization of the tumor excised. The clinical target volume (CTV) is defined as the tumor bed with a 1.5 cm margin limited by skin contour.
A dose of 40 Gy is delivered in 16 fractions (2.5 Gy per fraction). For conventional post-mastectomy radiotherapy this moderately hypofractionated schedule is considered feasible and safe (31). Even more so, this schedule should be feasible and safe for a smaller irradiated volume as in the current protocol. Regional nodal irradiation is not considered at our Institution for patients fulfilling the entry criteria of the protocol.
OUTCOME MEASURES Primary To assess feasibility of PCWRT via VMAT-IGRT linac-based or helical Tomotherapy To assess the safety of PCWRT via VMAT-IGRT linac-based or helical Tomotherapy To assess the surgical complication of implant-based breast reconstruction after PCWRT Secondary To assess the cosmetic outcome of implant-based breast reconstruction after PCWRT To assess patients' satisfaction of implant-based breast reconstruction after PCWRT
详细描述
There is uncertainty on the indications to chest wall irradiation in patients submitted to mastectomy plus immediate implant-based reconstruction with: A) negative axillary nodes and additional risk factors; B) 1-3 positive axillary nodes and no additional risk factors.
The reduction of locoregional recurrences is valuable from a clinical and psychological standpoint and may also translate into a survival advantage. Nevertheless, whole chest wall radiotherapy can be associated with significant toxicity due to irradiation of non-target organs and does significant worsen the cosmetic result of prosthetic-based breast reconstruction (capsular contracture, implant displacement, infection).
Most Institution have adopted NAC sparing mastectomy as standard treatment for non-locally advanced breast cancer patients not amenable to breast conserving surgery. Available literature data, including our own data, suggest that in these patients local recurrence in the NAC area is exceedingly rare, while most local recurrences occur where the original tumor was located.
It is now accepted that, in selected breast cancer patient submitted to breast conserving surgery, accelerated partial breast radiotherapy is associated with similar recurrence rates as compared to whole breast radiotherapy and favorable cosmetic outcomes. Therefore, we hypothesize that partial chest wall radiotherapy of the quadrant where the original tumor was located after NAC sparing mastectomy may be associated with the same reduction of local recurrences while significantly reducing the complications of prosthetic-based breast reconstruction.
STUDY DESCRIPTION:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of in situ ductal carcinoma (pTis) or invasive breast carcinoma (pT1 and pT2), submitted to NAC sparing mastectomy with prosthetic-based breast reconstruction (expander or prosthesis) and:
- •Negative sentinel node dissection or axillary clearance (pN0) and all the following risk factors:
- •Close (less than 1 mm) or positive (ink on tumor margin) surgical margin in a single breast quadrant
- •Tumor diameter >2 cm
- •Age ≤50 years
- •Grade 3 histology
- •Positive sentinel dissection (pN1a) followed by axillary clearance (or primary axillary clearance) with only 1 positive node and any of the following risk factors:
- •Close (less than 1 mm) or positive (ink on tumor margin) surgical margins in a single breast quadrant
- •Age ≤50 years
- •Tumor diameter >2 cm
- •Grade 3 histology
- •Lymphovascular invasion
- •HER-2 overexpression/amplification
- •Triple negativity
- •Patients must be older than 18 and less than 81 years of age
- •WHO (ECOG) Performance Status of 0-2
- •Patients must consent to return for scheduled treatments and follow up
- •Written informed consent document signed
排除标准
- •Stages IIIB, IIIC and IV (any T4, any N3 or M1)
- •Pathological metastasis in ≥2 axillary lymph nodes, clinically apparent metastasis in internal mammary and/or supraclavicular lymph nodes
- •Close (less than 1 mm) or positive (ink on tumor margin) surgical margin in multiple breast quadrants
- •Patients submitted to neoadjuvant chemotherapy
- •Recurrence of breast cancer following mastectomy and/or adjuvant chemotherapy.
- •Concomitant primary cancer in the contralateral breast
- •History of other malignancy except carcinoma in situ of the cervix or non-melanoma skin cancer
- •Pregnant or breast-feeding
- •Other severe concomitant disease that could impact upon the ability to deliver treatment or increase the risk of toxicity (such as uncompensated congestive heart failure, unstable coronary heart disease, uncompensated chronic obstructive pulmonary disease, collagen vascular diseases including systemic lupus erythematosus, systemic sclerosis, dermatomyositis, and ataxia telangiectasia)
- •Contraindications to radiation therapy (such as previous irradiation of the breast or chest wall)
- •Severe psychiatric disorder that may interfere with the process of informed consent and/or treatment or follow-up compliance
研究组 & 干预措施
PCWRT Group
Patients with diagnosis of in situ ductal carcinoma (pTis) or invasive breast carcinoma (pT1 and pT2), submitted to NAC sparing mastectomy with prosthetic-based breast reconstruction who have some additional risk factors will receive a partial chest wall radiotherapy
干预措施: Partial chest wall radiation therapy (Radiation)
结局指标
主要结局
Assess feasibility , defined as patient set-up reproducibility, plan reproducibility through in vivo dosimetry and dosimetrical reduction of PCWRT vs. conventional chest wall radiotherapy
时间窗: 5 weeks
Evaluation of reproducibility of the technique. Evaluation of dose administered to non-target organ.
次要结局
- Assess safety basing on RTOG ACUTE Radiation Morbidity and RTOG/EORTC LATE Radiation Morbidity(6-24 months following the completion of radiation therapy)
- Assess surgical complication using a four-step scale of capsular contracture after prosthetic breast reconstruction(6, 12, 18 and 24 months following the completion of radiation therapy)
- Assess cosmetic outcome using a qualitative scale (excellent-good-fair-poor)(1, 3, 6, 12, 18 and 24 months following the completion of radiation therapy)
- Assess patients' satisfaction throuhg a questionnaire administered to patients(12 months following the completion of radiation therapy)