Personalized Radiation Therapy Through Functional Lung Avoidance and Response-Adaptive Dose Escalation: Utilizing Multimodal Molecular Imaging to Improve the Therapeutic Ratio (FLARE RT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Overall Survival (OS) Rate
研究概览
简要总结
This phase II trial studies how well positron emission tomography (PET)/computed tomography (CT) and single positron emission computed tomography (SPECT)/CT imaging works in improving radiation therapy treatment in patients with stage IIB-IIIB non-small cell lung cancer. PET/CT imaging mid-way through treatment may be able to accurately show how well radiation therapy and chemotherapy are working. SPECT/CT imaging may be able to tell which parts of the lung tissue are healthier than others. Based on the result of the imaging, treatment adjustments may be made to the radiation therapy to improve survival and decrease toxicity.
详细描述
OUTLINE: This is a dose-escalation study of radiation therapy.
Patients undergo functional avoidance radiation therapy during weeks 1-3. Patients undergo fludeoxyglucose F-18 FDG PET/CT at baseline, 3 weeks, and 3 months post-radiation therapy and undergo technetium Tc-99m albumin aggregated (99mTc-MAA) and technetium Tc-99m sulfur colloid SPECT/CT radiation therapy at baseline and 3 months post-radiation therapy. Baseline PET/CT must be performed at University of Washington Medical Center/Seattle Cancer Care Alliance and be within one month of treatment start, therefore some patients may need to repeat a baseline PET/CT if their PET/CT is from an outside institution or > 1 month old. Patients not responding to treatment at 3 weeks, will receive an increased daily radiation therapy dosage.
After completion of study treatment, patients are followed up for 2 years.
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
- •Pathologically proven (either histologic or cytologic) diagnosis of stage IIB-IIIB non-small cell lung cancer (NSCLC); according to American Joint Committee on Cancer (AJCC) staging, 7th edition
- •Staging workup must include: brain imaging (CT head or magnetic resonance imaging [MRI] brain) and PET/CT
- •Pleural effusions must have cytology to rule out malignant involvement unless too small to undergo thoracentesis per radiology
- •Patients must be considered unresectable or inoperable
- •Patient must not have received prior radiation for this lung cancer
- •Patients must be having concurrent chemotherapy
- •Nodal recurrences can be treated on this protocol but prior curative surgery for lung cancer must have been at least 6 months prior to the nodal recurrence
- •Patients must have measurable or evaluable disease that is FDG avid with standardized uptake value (SUV) > 3 on PET/CT
- •Zubrod performance status 0-1
- •PFTs including forced expiratory volume in 1 second (FEV1) within 26 weeks prior to registration; for FEV1, the best value obtained pre- or post-bronchodilator must be >= 0.8 liters/second or >= 50% predicted
- •Blood cell count (CBC)/differential obtained within 8 weeks prior to registration on study
- •Absolute neutrophil count (ANC) >= 1,800 cells/mm^3
- •Platelets >= 100,000 cells/mm^3
- •Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 10.0 g/dl is acceptable)
- •Serum creatinine within normal institutional limits or creatinine clearance >= 40 ml/min
- •Bilirubin must be within or below normal institutional limits
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x the institutional upper limit of normal (IULN)
- •Patient must sign study specific informed consent prior to study entry
排除标准
- •> 10% unintentional weight loss within the past month
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; non-invasive conditions such as carcinoma in situ of the breast, oral cavity, or cervix are all permissible
- •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- •Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
结局指标
主要结局
Overall Survival (OS) Rate
时间窗: At 2 years
Final statistical analyses of OS will consist of Kaplan-Meier estimation.
次要结局
- Progression-free Survival (PFS)(1 year)
- Change in Pulmonary Function (Diffusing Capacity of the Lungs for Carbon Monoxide [DLCO])(Baseline to 3 months post-radiation therapy)
- Radiation Pneumonitis Defined as Common Terminology Criteria for Adverse Events Version 4 Grade 2 or Higher Pneumonitis(Up to 3 months)
- Change in Pulmonary Function-forced Expiratory Volume in 1 Second (FEV1)(Baseline to 3 months post-radiation therapy)
- Local-Regional Progression as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria(At 1 year)
研究者
Jing Zeng
Professor
University of Washington