Multi-institution Phase II Trial of Intraoperative Electron Beam Radiotherapy Boost at the Time of Breast Conserving Surgery With Oncoplastic Reconstruction in Women With Early-Stage Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 5
- 主要终点
- Incidence of adverse events in the first 30 patients enrolled as graded by the National Cancer Institute Common Toxicity Criteria version 4.0
研究概览
简要总结
This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to the tumor cavity during the breast surgery before reconstruction may be a better way to kill tumor cells and shrink tumors.
详细描述
PRIMARY OBJECTIVES:
I. To determine the rate of grade 3 breast fibrosis at 1 year in women undergoing lumpectomy with oncoplastic reconstruction and immediate intraoperative electron radiotherapy boost followed by adjuvant whole breast radiotherapy.
SECONDARY OBJECTIVES:
I. To determine the rate of 5 year ipsilateral breast tumor recurrence rate. II. To determine the change in self-reported cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire.
III. To evaluate physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven diagnosis of breast cancer
- •Clinical node negative stage I (T1N0) or stage II (T2N0) breast cancer
- •Preoperative ultrasound of the axilla with biopsy of suspicious nodes is recommended as clinically indicated per the discretion of the treating physician
- •Appropriate stage for protocol entry including no clinical evidence for distant metastases based upon the following minimum diagnostic workup
- •History/physical examination, documentation of weight and Zubrod performance status 0-2 within 28 days prior to study entry
- •Right and left mammography within 90 days of diagnostic biopsy establishing diagnosis
- •Absolute neutrophil count > 1800 cells/cubic mm
- •Platelets >= 75,000 cells/cubic mm
- •Hemoglobin >= 8 g/dL
- •Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry
- •Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
- •Patients must provide study specific informed consent prior to study entry
排除标准
- •Clinical T4, N2 or N3, M1 pathologic stages III or IV breast cancer
- •Prior invasive non-breast malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 3 yrs prior to study entry
- •Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ [LCIS] is eligible)
- •Two or more cancers not resectable through a single lumpectomy incision
- •Bilateral breast cancer
- •Ductal breast carcinoma in situ (DCIS) only
- •Non-epithelial breast malignancies such as sarcoma/lymphoma
- •Male breast cancer
- •Paget's disease of the nipple
- •Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation fields
- •Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
- •Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
- •Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent
研究组 & 干预措施
Treatment (IOERT boost)
Patients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
干预措施: Electron Beam Therapy (Radiation)
Treatment (IOERT boost)
Patients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
干预措施: Questionnaire Administration (Other)
Treatment (IOERT boost)
Patients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
干预措施: Lumpectomy (Procedure)
Treatment (IOERT boost)
Patients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
干预措施: Quality-of-Life Assessment (Other)
Treatment (IOERT boost)
Patients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
干预措施: Radiation Therapy (Radiation)
Treatment (IOERT boost)
Patients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
干预措施: Reconstructive Surgery (Procedure)
结局指标
主要结局
Incidence of adverse events in the first 30 patients enrolled as graded by the National Cancer Institute Common Toxicity Criteria version 4.0
时间窗: Up to 30 days after surgery and IOERT boost
If 4 or more complications in the first 10 patients, 7 or more out of the first 20 patients or 9 or more out of 30 patients are observed, then the study will be deemed not safe to continue. Summary statistics will be used to report all complications.
Rate of grade 3 fibrosis using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales
时间窗: At 1 year from the end of therapy
The proportion of patients with an overall response rate of grade 3 fibrosis at 1 year from the end of therapy along with the exact binomial confidence interval for the rate will be calculated.
次要结局
- Quality of life assessed by Breast Cancer Treatment Outcome Scale(Up to 3 years after completion of radiation therapy)
- Change in self-reported cosmesis using the BCTOS(Baseline up to 3 years)
- Physician reported cosmesis using the Harvard Breast Cosmesis scale and digital photographs(Up to 3 years after completion of radiation therapy)
- Rate of ipsilateral breast tumor recurrence(At 5 years)
研究者
Sachin Jhawar
Principal Investigator
Ohio State University Comprehensive Cancer Center