Phase II Study of Accelerated and Adaptive Radiation Therapy for Locally-Advanced Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The Metabolic Complete Response Rate, Assessed Using Interim PET-CT, in an Accelerated Fashion (2 Gy/Fraction, 6 Fractions/Week) With Concurrent Chemotherapy
研究概览
简要总结
This is a prospective phase II study designed to evaluate an accelerated and adaptive RT approach for locally-advanced non-small cell lung cancer (NSCLC). All eligible subjects will have an interim PET-CT during radiation therapy to determine the metabolic complete response rate. Radiation therapy will be given in an accelerated fashion (2 Gy/fraction, 6 fractions/week) with concurrent chemotherapy. Interim responses will be assessed using PERCIST criteria.
Despite concurrent chemotherapy and radiation therapy, local/regional failure occurs in ~50% of patients with locally-advanced NSCLC. Clinical studies have demonstrated that accelerated fractionation (giving the same total dose in a shorter period of time) improves outcomes in several malignancies, including lung cancer. Administering higher than conventional doses of RT to all sites of original disease leads to inferior outcomes. Adapting the RT approach, giving a higher dose to slowly responding disease as assessed with interim PET has been shown to be feasible. PERCIST (Positron Emission Tomography Response Criteria in Solid Tumors) provides guidelines on how to report responses to therapy based on PET-CT. PET-CT response has been shown to be prognostic in a variety of clinical scenarios in lung cancer including after induction therapy. In one study, PET was performed after neoadjuvant chemoradiotherapy (40-50.4 Gy). Complete or partial metabolic response using PERCIST criteria was predictive of loco-regional, distant, and overall progression-free survival.
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
- •Histologic/cytologic documentation of non-small cell lung cancer (NSCLC)
- •Unresectable stage II, IIIA, or IIIB disease
- •Zubrod/ECOG performance status 0-1
- •Weight loss < 10% in preceding 3 months prior to diagnosis
- •Adequate organ function defined as the following
- •Absolute neutrophil count of ≥ 1,500 and platelet count ≥ 100,000
- •Cockcroft calculated creatinine clearance of ≥ 45 ml/min or 1.5 x the upper limit of normal (ULN)
- •A total bilirubin ≤ 1.5 ULN, aspartate aminotransferase (AST) ≤ 2.0 x ULN
- •≥ 18 years of age.
- •Negative pregnancy test in women of child-bearing potential
- •Signed study-specific informed consent.
- •No prior chemotherapy or radiotherapy for NSCLC
- •No prior mediastinal or thoracic radiation
排除标准
- •Prior thoracic irradiation.
- •Medical contraindications to thoracic irradiation.
- •Pre-existing sensory neuropathy of grade ≥ 2
- •Pleural effusion: when pleural fluid is visible on both CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
- •Patients with effusions that are minimal (i.e. not visible on chest x-ray) or that are too small to safely tap are eligible
- •Patients with contralateral hilar involvement
研究组 & 干预措施
Carboplatin/Paclitaxel with radiation therapy
Single arm, non randomized, open label study. Eligible subjects will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
干预措施: Carboplatin (Drug)
Carboplatin/Paclitaxel with radiation therapy
Single arm, non randomized, open label study. Eligible subjects will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
干预措施: Paclitaxel (Drug)
Carboplatin/Paclitaxel with radiation therapy
Single arm, non randomized, open label study. Eligible subjects will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
干预措施: Daily hyperfractionated radiation therapy (Radiation)
结局指标
主要结局
The Metabolic Complete Response Rate, Assessed Using Interim PET-CT, in an Accelerated Fashion (2 Gy/Fraction, 6 Fractions/Week) With Concurrent Chemotherapy
时间窗: 4 weeks
For the cohort of the participants who meet eligibility criteria and receive radiotherapy with concurrent chemotherapy, the metabolic complete response (MCR) rate will be measured with interim PET-CT utilizing PERCIST response reporting criteria.
次要结局
- Number of Participants With Local Control With an Accelerated and Adaptive RT Approach(2 years)
- The Number of Participants Eligible for an RT Boost After Completing a Standard Dose of RT (60 Gy), Delivered in an Accelerated Fashion (6 Fractions/Week) With Concurrent Chemotherapy(4 weeks)
- Overall Survival With an Accelerated and Adaptive RT Approach.(2 years)
- Progression-free Survival (PFS) With an Accelerated and Adaptive RT Approach.(2 years)