Phase I Study: Locally Invasive NSCLC Treated With NEo-Adjuvant Stereotactic Body Radiotherapy and REsection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of SBRT followed by surgery (proportion of patients who can undergo 10 fractions of SBRT followed by Surgery)
研究概览
简要总结
Despite improved staging and operative techniques, the rate of incomplete resection (R1) of NSCLC has remained significant over the last decades. Patients with R1 resection have significantly worse survival compared to those with complete resection (R0).
This is a phase I study that investigates the feasibility and safety of delivering Stereotactic Body Radiotherapy (SBRT) to patients with locally invasive NSCLC (cT3-4, N0-1) who are at risk for incomplete resection.
Twenty patients with NSCLC will be treated with SBRT followed by surgery and appropriate adjuvant therapy. Patients will be divided into groups, of 5 patients each, treated with escalating doses (35, 40, 45 and 50 Gy) in 10 daily fractions.
The primary outcome is the feasibility i.e. the ability to complete safely SBRT and surgery (within 6 weeks). Secondary outcomes include acute and late adverse events, R0/R1/R2 rates and secondary surrogates of feasibility.
If successful, this study will lead to further evaluation of pre-operative SBRT in NSCLC.
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
- 是
入选标准
- •Patients will be included if they are aged 18 years or older,
- •with biopsy proven NSCLC,
- •clinically staged T3-T4 marginally resectable i.e. deemed at risk to achieve <R0 resection (such as invasion of critical mediastinal or hilar structures, nodal extra-capsular extension, chest wall, vertebral bodies, compromised bronchial stump margin, based on CT images of the chest).
- •Patients also need to be pathologically staged N0-1 disease,
- •with an SBRT CTV≤200cm3, based on planning CT images.
- •ECOG status is required to be <2 within 4 weeks prior to registration and
- •patients must be deemed medically operable by the surgical team.
排除标准
- •Patients will be excluded if they are deemed medically inoperable by the surgical team
- •and have a weight loss of ≥10% within 3 months prior to pathological diagnosis.
- •Patients will also have no absolute contraindication to RT such as connective tissue disease, pacemaker-dependent patient with the pacemaker receiving higher than tolerance dose, had no had previous RT to the current region of the study, that would result in overlap of RT fields,
- •patients must have no plans to receive other local therapy while on study, except at disease progression,
- •patients have not had other malignancy within 2 years prior to the study (other than non-melanomatous skin cancers)
研究组 & 干预措施
Neoadjuvant stereotactic body radiation
Single arm study. Four cohorts of 5 patients will undergo neo-adjuvant SBRT for lung cancer. Eligible patients will have operable, borderline resectable lung cancer , they will be treated with SBRT, prior to undergoing surgical resection.
干预措施: Neoadjuvant Stereotactic body radiation (SBRT) (Radiation)
结局指标
主要结局
Feasibility of SBRT followed by surgery (proportion of patients who can undergo 10 fractions of SBRT followed by Surgery)
时间窗: 18 months
Feasibility of neo-adjuvant SBRT followed by surgery. This will be measured as the proportion of patients who can undergo 10 fractions of SBRT followed by Surgery as scheduled (within 6 weeks from registration).
次要结局
- Early safety of SBRT-S through collection of serious adverse events (CTCAE version 4.0 grade 3 or higher) from beginning of SBRT to 4 weeks after completion of surgery.(18 months)
- Late safety profile of SBRT-S through collection of surgical complication rates assessed at 6 and 18 months post-registration (thus 30 months from opening of the study, assuming it takes 1 year to complete accrual).(30 months)
- Secondary feasibility outcomes (including accrual rate, consent rate, rates of deviation from scheduled treatment plan, and reasons for delay)(18 months)
- Pathological response following neoadjuvant SBRT (proportion of R0, R1 and R2 resections)(18 months)
- Pathologic changes associated with neo-adjuvant SBRT with analysis of irradiated tissues(18 months)
研究者
Theo Tsakiridis, M.D., Ph.D., FRCPC
Radiation Oncologist, Associate Professor
Juravinski Cancer Center