A Phase II Study of Non-Coplanar SBRT Re-Irradiation Using HyperArc in Patients With Recurrent Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Local control rate of the treated tumor target per Response Evaluation Criteria in Solid Tumors version 1.1, magnetic resonance imaging (MRI) response or positron emission tomography (PET) response
研究概览
简要总结
This phase II trial studies how well stereotactic body radiation therapy with HyperArc software technology works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate local control and toxicity of patients who receive escalated dose stereotactic body radiation therapy (SBRT) reirradiation with HyperArc for recurrent head and neck cancer (rHNC).
SECONDARY OBJECTIVES:
I. To evaluate the clinical benefit of HyperArc through the analysis of overall survival (OS), progression-free survival (PFS) and locoregional progression-free survival (LPFS).
EXPLORATORY OBJECTIVES:
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed recurrent head and neck cancer; either unresectable or status post salvage surgery.
- •History of radiation therapy for head and neck cancer with minimum 50% overlap of the 50% isodose line from prior treatment to the proposed treatment volume.
- •Estimated life expectancy > 12 weeks.
- •Karnofsky performance status >= 70 (Eastern Cooperative Oncology Group [ECOG] 0-2).
- •Maximum tumor, or tumor bed, diameter < 5 cm.
- •If a woman is of childbearing potential, a negative serum pregnancy test must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study treatment.
- •Ability to understand and willingness to sign a written informed consent.
排除标准
- 未提供
结局指标
主要结局
Local control rate of the treated tumor target per Response Evaluation Criteria in Solid Tumors version 1.1, magnetic resonance imaging (MRI) response or positron emission tomography (PET) response
时间窗: At 1 year
Will calculate the percentage and construct 95% exact confidence interval for local control rate.
Percent of patients with acute or chronic grade >= 3 treatment-related toxicity per Common Terminology Criteria for Adverse Events version 4.0
时间窗: At 1 year
Data will be tabulated and summarized. Incidence of adverse events (AEs) will be summarized overall and with separate summaries for serious adverse events (SAEs), AEs leading to discontinuation, AEs leading to death, etc. The overall safety and tolerability will be assessed throughout the study period. All AE data will be listed individually by patient identifier.
次要结局
- Overall survival (OS)(The time between the first dose of stereotactic body radiation therapy (SBRT) and death, assessed at 1 year)
- OS(The time between the first dose of SBRT and death, assessed at 2 years)
- PFS(From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed at 2 years)
- Median PFS(From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed up to 2 years)
- LPFS(From the first dose of SBRT to the first objectively documented disease progression in either the primary tumor, adjacent to the primary tumor, or in the surrounding lymph node areas, assessed at 2 years)
- Median LPFS(From the first dose of SBRT to the first objectively documented disease progression in either the primary tumor, adjacent to the primary tumor, or in the surrounding lymph node areas, assessed up to 2 years)
- Median OS(The time between the first dose of SBRT and death, assessed up to 2 years)
- Progression-free survival (PFS)(From the first dose of SBRT to the first objectively documented disease progression or death due to any cause, assessed at 1 year)
- Locoregional progression-free survival (LPFS)(From the first dose of SBRT to the first objectively documented disease progression in either the primary tumor, adjacent to the primary tumor, or in the surrounding lymph node areas, assessed at 1 year)