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临床试验/NCT02773238
NCT02773238
已完成
2 期

Personalized Radiation Therapy Through Functional Lung Avoidance and Response-Adaptive Dose Escalation: Utilizing Multimodal Molecular Imaging to Improve the Therapeutic Ratio (FLARE RT)

University of Washington2 个研究点 分布在 1 个国家目标入组 51 人2016年5月20日

概览

阶段
2 期
干预措施
未指定
疾病 / 适应症
Stage IIB Lung Non-Small Cell Carcinoma AJCC v7
发起方
University of Washington
入组人数
51
试验地点
2
主要终点
Overall Survival (OS) Rate
状态
已完成
最后更新
去年

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.

注册库
clinicaltrials.gov
开始日期
2016年5月20日
结束日期
2023年12月1日
最后更新
去年
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

Jing Zeng

Professor

University of Washington

入排标准

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

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)

研究点 (2)

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