The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Duration of Local Control
研究概览
简要总结
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects of stereotactic radiosurgery in treating patients with locally advanced or recurrent head and neck cancer.
详细描述
OBJECTIVES:
- To determine the feasibility and tolerability of CyberKnife® stereotactic radiosurgery as boost therapy after standard chemoradiotherapy in patients with locally advanced head and neck cancer.
- To determine the feasibility and tolerability of CyberKnife® stereotactic radiosurgery as salvage therapy in patients with locally recurrent head and neck cancer.
OUTLINE: Patients are assigned to 1 of 2 treatment groups according to disease status after prior standard therapy. Patients with residual disease after standard therapy are assigned to group 1. Patients with recurrent disease ≥ 6 months after standard therapy are assigned to group 2.
All patients undergo placement of 3-6 gold fiducial markers within 1-2 weeks of beginning CyberKnife® stereotactic radiosurgery (SRS) treatment.
- Group 1 (CyberKnife® SRS boost therapy): Patients undergo CyberKnife® SRS boost therapy (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
- Group 2 (CyberKnife® SRS salvage therapy): Patients undergo CyberKnife® SRS salvage therapy (5 fractions) 3 times weekly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Biopsy-confirmed* invasive head and neck cancer, including the following primary sites:
- •Nasopharynx
- •Oropharynx
- •Paranasal sinus
- •Oral cavity
- •Salivary gland NOTE: *Biopsy must be performed prior to initiation of external beam radiotherapy (EBRT)
- •Stage T2-4 tumor at the time of diagnosis
- •Primary tumor ≤ 5 cm in diameter at the time of CyberKnife® stereotactic radiosurgery (SRS)
- •Meets one of the following criteria:
- •Eligible for CyberKnife® SRS as boost therapy, as defined by one of the following criteria:
- •Planning to undergo definitive EBRT, with or without chemotherapy, with curative intent for primary head and neck cancer
- •Biopsy-confirmed locally persistent disease < 3 months after completion of definitive EBRT
- •Eligible for CyberKnife® SRS as salvage therapy*, as defined by one of the following criteria:
- •Biopsy-confirmed locally recurrent disease occurring ≥ 6 months after the completion of radiotherapy; achieved a complete response to initial therapy by imaging or clinical examination; had > 50% of the tumor volume in the prior irradiated volume; and received > 45 Gy of radiotherapy
- •Biopsy-confirmed locally recurrent disease occurring between 6 weeks and 6 months after the completion of radiotherapy; achieved a complete response to initial therapy by imaging or clinical examination; had < 50% of the tumor volume in the prior irradiated volume; and received > 45 Gy of radiotherapy NOTE: *Not a candidate for salvage surgery or brachytherapy
- •Anticipated total dose of radiotherapy to the spinal cord ≤ 50 Gy (including prior dose)
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 60-100%
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Able to achieve normal tissue tolerance to critical structures with the CyberKnife® planning system
- •Able to undergo CT simulation
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- •No laryngeal or hypopharyngeal cancer
- •No evidence of distant metastases
- •No prior brachytherapy
- •No prior CyberKnife® SRS boost or salvage therapy
- •No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No active connective tissue disorders (e.g., lupus or scleroderma)
研究组 & 干预措施
Group 1 (CK SRS boost therapy)
Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
干预措施: stereotactic radiosurgery (Radiation)
Group 2 (CK SRS salvage therapy)
Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.
干预措施: stereotactic radiosurgery (Radiation)
结局指标
主要结局
Duration of Local Control
时间窗: 1 year
Median time to local failure based on regional or distant metastatic disease
次要结局
- Rates of Adverse Events Associated With Treatment(1 year)
研究者
Minh Tam Truong
BMC Attending Physician
Boston Medical Center