A Feasibility and Toxicity Analysis of Single Fraction Stereotactic Body Radiation Therapy for Post-Operative Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of grade 3 or greater toxicities
研究概览
简要总结
This trial studies the side effects of single fraction stereotactic body radiation therapy after surgery in treating patients with non-small cell lung cancer. Standard radiation for lung cancer involves delivering small doses of daily radiation for several weeks. However, this technique has resulted in inferior outcomes compared to surgery and is associated with damage to surrounding normal lung. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. Giving stereotactic body radiation therapy in fewer treatment sessions (single fraction) may kill tumor cells and cause less damage to normal tissue.
详细描述
PRIMARY OBJECTIVES:
I. Assess feasibility and toxicity of single-fraction stereotactic body radiation therapy (SBRT) in the post-operative setting.
SECONDARY OBJECTIVES:
I. Assess quality of life following post-operative single-fraction SBRT. II. Assess rate of in-field failures.
TERTIARY 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
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Has completed curative-intent surgical resection of lung primary with pathologic diagnosis of NSCLC disease, with pathology to include at least 1 of the following:
- •Close (<=2 mm) or Positive surgical margin (R1/R2) or pathologic N2 disease (with or without extracapsular extension [ECE])
- •Anatomic pulmonary resection (lobectomy or pneumonectomy) preferred, although sublobar resection is allowed at the discretion of the treating surgeon. Systemic lobe-specific nodal sampling is required. A minimum of 3 N2 stations must be sampled. Selective lymph node dissection should be completed for patients with known N2 disease
- •Women of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence)
- •Patient or legal representative must be willing and able to participate in protocol requirements, including pre- and post-treatment survey evaluations and clinical assessments
- •Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Contraindication to SBRT
- •This includes the inability to cooperate with any aspect of SBRT such as the inability to lie still and breath reproducibly
- •Prior radiation therapy targeting the same area for which radiation treatment is being planned
- •Pregnant or nursing female patients
- •Unwilling or unable to follow protocol requirements
- •Any condition which, in the investigator?s opinion, deems the patient unable to participate in enrollment
- •Patients who undergo sublobar resection but are unable to undergo appropriate N1 and N2 lymph node sampling
研究组 & 干预措施
Treatment (SBRT)
Beginning at least 2 weeks after surgical resection, patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT.
干预措施: Quality-of-Life Assessment (Other)
Treatment (SBRT)
Beginning at least 2 weeks after surgical resection, patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT.
干预措施: Questionnaire Administration (Other)
Treatment (SBRT)
Beginning at least 2 weeks after surgical resection, patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
结局指标
主要结局
Incidence of grade 3 or greater toxicities
时间窗: Up to 5 years
Hospitalization resulting from radiation treatment will be recorded. Any acute (=\< 180 days after the end of radiation therapy \[RT\]) and late (\> 180 days after the end of RT) toxicities will be documented using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals (alpha = 0.10).
Feasibility of single fraction SBRT
时间窗: Up to 5 years
Feasibility will be assessed by the median time to initiation of systemic treatment (TST) following the combination of surgery and stereotactic body radiation therapy (SBRT), as this interval will reflect the probability of completing intended treatment.
次要结局
- Quality of life (QoL)(Up to 5 years)
- In-field failure (IFF) rate(Up to 5 years)
- Time to initiation of systemic treatment (TST)(From the date of surgery until the date of systemic treatment initiation, assessed up to 5 years)