NCT01871454招募中2 期
Effect of Pentoxifylline and Vitamin E in Preventing Radiation-induced Toxicity in the Treatment of Recurrent or New Primary NSCLC Using Stereotactic Ablative Radiotherapy in Patients Previously Treated With Thoracic Radiation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- primary endpoint is to estimate overall treatment-related toxicity
研究概览
简要总结
The objective of this prospective phase II protocol is to assess the toxicity and efficacy of pentoxifylline and SABR in the re-treatment of recurrent or new lung cancers
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
- •Eligibility Criteria
- •3.1.1 Age >/= 18 years
- •3.1.2 ECOG performance status 0-1 3.1.3 Histologically proven diagnosis of a prior thoracic malignancy treated with thoracic external beam radiotherapy with or without systemic chemotherapy
- •3.1.4 Pathologic or clinical diagnosis of a new or loco-regional recurrent lung malignancy. A reasonable attempt should be made to make a pathologic diagnosis of malignancy (ie. bronchoscopy, CT guided lung biopsy)
- •Loco-regional is defined as recurrence within the region of the primary tumor or adjacent draining lymph node regions.
- •The new lesion or loco-regional recurrence must be within or adjacent to the previously irradiated treatment volume.
- •3.1.5 Imaging as follows:
- •CT scan of the chest with IV contrast within 8 weeks of registration
- •Whole body PET scan within 8 weeks of registration
- •3.1.6 Pulmonary function test (PFTs), including diffusion capacity within 8 weeks of registration
- •3.1.7 Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
- •3.1.6 Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
- •3.1.7 Patients must provide study specific informed consent prior to study entry.
排除标准
- •3.2 Exclusion Criteria
- •No previously reported thoracic radiotherapy
- •FEV1 <20% predicted and/or DLCO <20% predicted
- •Pregnant women or lactating women
- •3.2.3 Chemotherapy within 4 weeks of the initiation of SABR
- •3.2.4 Plans to administer systemic chemotherapy overlapping with radiotherapy
研究组 & 干预措施
radiotherapy (SABR) plus pentoxifylline
Experimental
standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E
干预措施: stereotactic ablative radiotherapy (SABR) (Radiation)
radiotherapy (SABR) plus pentoxifylline
Experimental
standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E
干预措施: Pentoxifylline (Drug)
结局指标
主要结局
primary endpoint is to estimate overall treatment-related toxicity
时间窗: 36 months-end of trial
次要结局
- Estimate progression free survival(12 months)
- Estimate tumor failure(12 months)
- estimate overall survival(12 months)
研究者
Neal Edward Dunlap
Associate Professor
University of Louisville
研究点 (1)
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