Phase II Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients with Implant Reconstructions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 7
- 主要终点
- efficacy of multi-beam IMRT
研究概览
简要总结
The purpose of this study is to determine if a radiation treatment called "Multi-beam Intensity Modulated Radiation Therapy"(IMRT) can reduce side effects related to your implant if they are a candidate for radiation therapy. Currently, the standard method of giving radiation is with "3D radiation", which only uses 2-5 beams of radiation. "Multi-beam" IMRT works by using 8-12 small radiation beams to give a more "tailored" or "customized" radiation dose to the implant, breast, chest wall and lymph nodes. At the same time, multi-beam IMRT may lower the radiation dose to the heart, lung and nearby tissues. The goal of the study is to reduce complications after irradiation to the implants.
The study doctors have recently completed a trial using this technique and are now specifically looking at its impact on women with implant reconstructions who are undergoing post-mastectomy radiation therapy. By delivering a more "customized" dose of radiation to the implant, the intent is to reduce side effects of radiation on the implant.
详细描述
Patients will undergo mastectomy and axillary dissection with immediate tissue expander placement. As is the current practice at MSKCC, patients receiving adjuvant chemotherapy will undergo expansion during chemotherapy, with exchange for a permanent implant to be performed approximately one month after chemotherapy and radiation to begin approximately one month after exchange. Patients who receive neoadjuvant chemotherapy will undergo "rapid expansion" of the expander and begin radiation at least 4 weeks following surgery, although it may be performed sooner if the patient has recovered from surgery and the treating physician deems it safe to proceed with treatment. In these patients, exchange for the permanent implant will occur at the discretion of the treating plastic surgeon (approximately 5-8 months after the end of radiation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females who are age ≥ 18 years of age with a life expectancy estimated to be at least 2 years
- •Histologically-confirmed invasive breast cancer by MSKCC
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Status post mastectomy with surgical assessment of axillary nodes
- •Immediate reconstruction with tissue expander (Group 2) or permanent implant (Group 1) prior to RT performed at MSKCC
- •If PMRT is recommended, the treatment fields will include the axillary, supraclavicular, and internal mammary nodes.
排除标准
- •Absence of a breast reconstruction prior to RT (placement of tissue expander is sufficient for group 2)
- •Pregnant or breastfeeding.
- •Psychiatric or addictive disorders that would preclude obtaining informed consent or filling out Breast-Q© questionnaires.
- •Prior radiation therapy to the ipsilateral breast/nodes or thorax.
- •The criterias outlined above apply to the patients enrolled to meet the primary objective of the study. Additional criteria for patients in the cardiac substudy portion of the protocol are outlined in the protocol
研究组 & 干预措施
Group 2
Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT
干预措施: Multi-Beam IMRT (Radiation)
Group 1
Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT. Total length of the follow-up time will be 24 ± 2 months post-IMRT. A subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session. A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time. Myocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.
干预措施: Breast MRI (Device)
Group 1
Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT. Total length of the follow-up time will be 24 ± 2 months post-IMRT. A subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session. A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time. Myocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.
干预措施: Breast-Q© questionnaire (Behavioral)
Group 1
Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT. Total length of the follow-up time will be 24 ± 2 months post-IMRT. A subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session. A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time. Myocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.
干预措施: Multi-Beam IMRT (Radiation)
Group 2
Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT
干预措施: Breast MRI (Device)
Group 2
Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT
干预措施: Breast-Q© questionnaire (Behavioral)
结局指标
主要结局
efficacy of multi-beam IMRT
时间窗: 30 months
The treatment would be considered efficacious if the incidence of implant failure is reduced by at least a relative 30% by the end of the study period (24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2).
次要结局
- rates of minor revisional surgeries(2 years)
- evaluate cosmesis(2 years)
- incidence of moderate to severe capsular contracture(30 months)