Phase I Study - Hypofractionated Cyberknife Radiotherapy Combined With Neoadjuvant Chemotherapy for Breast Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Maximum-tolerated dose of radiotherapy
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as docetaxel, epirubicin, cyclophosphamide, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy when given together with docetaxel followed by standard therapy in treating women with breast cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the tolerance to concurrent neoadjuvant docetaxel and cyberknife hypofractionated radiotherapy followed by standard treatment in women with breast cancer in order to find the maximum-tolerated dose of radiotherapy.
Secondary
- Evaluate the efficacy of the combination chemoradiotherapy.
- Evaluate breast-conserving surgery.
- Evaluate the quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed diagnosis of breast cancer
- •Unifocal disease
- •Non-metastatic disease
- •Not a candidate for breast-conserving surgery
- •No superficial breast cancer (defined as the distance between tumor and skin ≤ 1 cm)
- •Undergone MRI of the breast to define the macroscopic tumor volume
- •Undergone scanning of the breast to mark the location for radiotherapy
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- •No counter-indications to surgery, standard neoadjuvant chemotherapy, or insertion of an implantable venous device
- •No patient for whom clinical follow up is impossible for psychological, familial, social, or geographical reasons
- •No patients deprived of liberty or under trusteeship
- •PRIOR CONCURRENT THERAPY:
- •No prior ipsilateral breast irradiation
排除标准
- 未提供
研究组 & 干预措施
Cyberknife
干预措施: hypofractionated radiation therapy (Radiation)
Cyberknife
干预措施: stereotactic radiosurgery (Radiation)
Cyberknife
干预措施: neoadjuvant therapy (Procedure)
Cyberknife
干预措施: therapeutic conventional surgery (Procedure)
Cyberknife
干预措施: radiation therapy (Radiation)
Cyberknife
干预措施: image-guided radiation therapy (Radiation)
Cyberknife
干预措施: epirubicin hydrochloride (Drug)
Cyberknife
干预措施: cyclophosphamide (Drug)
Cyberknife
干预措施: docetaxel (Drug)
Cyberknife
干预措施: fluorouracil (Drug)
结局指标
主要结局
Maximum-tolerated dose of radiotherapy
时间窗: 6 months
次要结局
未报告次要终点