A Phase II Trial Investigating Acute Local Toxicities of Intraoperative Radiotherapy as a Boost Dose in Korean Breast Cancer Patients Undergoing Breast Conserving Surgery
试验速览
- 阶段
- 2 期
- 入组人数
- 215
- 试验地点
- 2
- 主要终点
- Acute local toxicity in breast receiving IORT
研究概览
简要总结
The purpose of this study is to evaluate acute local toxicity of IORT at the dose of 20 Gy for the replacement of boost-external beam radiotherapy in Korean women who are candidates for breast-conserving treatment.
详细描述
Local toxicity checklist
- Hematoma needing surgical evacuation
- Seroma needing more than three aspirations
- Skin breakdown or delayed wound healing
- Any complication needing surgical intervention
- Radiation Therapy Oncology Group (RTOG version 2.0) toxicity grade 3 or 4 for dermatitis, telangiectasia, pain in irradiated field, or other.
- Any complication of RTOG toxicity grade more than 2
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
- •Histologically confirmed and newly diagnosed non-metastatic operable primary breast cancer
- •Primary tumor <5cm, measured by ultrasonography - N0-3 (any N if resectable) and no evidence of distant metastasis (M) (isolated supraclavicular node involvement allowed)
- •Age ≥18-years women with good performance status (ECOG 0-1)
- •No breast operation is allowed except diagnostic biopsy
- •Women with ductal carcinoma in situ diagnosed by preoperative biopsy are allowed
排除标准
- •Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
- •Patients who received prior chemotherapy or radiotherapy for breast cancer
- •Patients who have history of cancer other than in situ uterine cervix cancer or non-melanoma skin cancer
- •The depth of tumor from skin measured by ultrasonography is less than 1cm.
- •Contraindications to breast conservative surgery
- •Multicentric breast cancer (tumors in more than one quadrant)
- •Diffuse malignant appearing microcalcification
- •Prior therapeutic radiation to the breast region
- •Small breast, which is not possible to achieve clear margins in relation to a cosmetically acceptable result
- •History of collagen vascular disease, such as active scleroderma and active lupus
- •Postoperative exclusion
- •Patients who require re-excision due to positive resection margin
- •The depth of cavity from skin after lumpectomy is less than 0.5cm
结局指标
主要结局
Acute local toxicity in breast receiving IORT
时间窗: Up to 6 months
Acute local toxicities of ipsilateral breast occurred within 6 months after IORT Local toxicity checklist * Hematoma needing surgical evacuation * Seroma needing more than three aspirations * Skin breakdown or delayed wound healing * Any complication needing surgical intervention * Radiation Therapy Oncology Group (RTOG version 2.0) toxicity grade 3 or 4 for dermatitis, telangiectasia, pain in irradiated field, or other. * Any complication of RTOG toxicity grade more than 2 Expected number of patients with acute local toxicites associated with IORT-booster treatement is 32. Considering a drop-out rate of 10%, the trial would need to enroll 215 patients in total.
次要结局
- Local tumor recurrence in ipsillateral breast(Up to 5 years)
- Cosmesis(Up to 2 years)
- Dosimetray(At time of surgery)
- Delayed local toxicity(Up to 5 years)
研究者
Joon Jeong
Professor
Gangnam Severance Hospital