A Randomized Phase II Trial to Assess the Efficacy and Safety of Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-Small Cell Lung Cancer Receiving Definitive Chemoradiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 78
- 试验地点
- 14
- 主要终点
- Reduction of local-regional failure rate
研究概览
简要总结
A randomized phase II trial to assess the efficacy and safety of selective metabolically adaptive radiation dose escalation in locally advanced non-small cell lung cancer receiving definitive chemoradiotherapy. Eligible and consenting patients will be randomized to receive conventional chemoradiotherapy or chemoradiotherapy with a radiation (RT) integrated boost. All patients will receive a fludeoxyglucose-positron emission tomography (FDG-PET) scan within two weeks prior to starting treatment. The primary outcome is to determine if dose escalation to metabolically active tumor subvolumes will reduce local-regional failure rate at 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Patients who are at least 18 years old and are able to consent
- •Patients who will undergo Chemo-RT as primarily modality of treatment
- •Patients with a primary tumor or node measuring at least 10mm on CT scan
- •Patients with a PET avid tumor having Standardized Uptake Values (SUV) > 4
- •Patients with Eastern Cooperative Oncology Group (ECOG) status 0-2 within 4 weeks of randomization
排除标准
- •Trimodality patients who have surgery as part of curative treatment
- •Previous radiotherapy to intended treatment volumes
- •Active invasive malignancy other than lung cancer
- •Active pregnancy
- •Poor respiratory function (Forced Expiratory Volume < 1.0 or Diffusing Capacity < 50% age-adjusted normal)
- •ECOG status > 2
- •Pre-treatment complete blood count/differential showing inadequate bone marrow reserve (absolute neutrophil count < 1800 cells/mm3 or platelets < 100 000 cells/mm3 or hemoglobin < 90g/L), measured within 4 weeks of registration
- •AST, ALT or total bilirubin > 2.5 times the upper limit of normal, measured within 4 weeks of registration
- •Unintentional weight loss >10% over 3 months within 4 weeks of registration
- •Severe active co-morbidity defined by:
- •Significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, myocardial infarction within the last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction
- •Transmural myocardial infection requiring intravenous antibiotics at the time of registration
- •Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization
- •Acquired immune deficiency syndrome (AIDS) based on the current Centre for Disease Control definition; note, however, that HIV testing is not required for entry into this protocol
结局指标
主要结局
Reduction of local-regional failure rate
时间窗: 2 years
Primary outcome of the trial is to determine if dose escalation to metabolically active subvolumes will reduce local-regional failure rate
次要结局
- Overall Survival(2 years)
- Grade 3-5 Toxicity Rate(2 years)
- Imaging Use(2 years)
- Quality of Life FACT-L(2 years)
- Dose Escalation Feasibility(2 weeks)
- Dose-Response Characterization(2 years)
- Progression-Free Survival(2 years)
- Quality of Life EQ-5D(2 years)
研究者
David Palma
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's