Phase I Study of Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-IV Non-Small Cell Lung Cancer and Poor Performance Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Number of Participants With Dose Limiting Toxicity
研究概览
简要总结
The study is designed to determine whether daily image guidance and motion assessment/control will allow treatment of poor performance status patients with stage II-IV NSCLC, who would benefit from local therapy, with an accelerated course of hypofractionated radiation therapy.
详细描述
Subjects for this study will be enrolled by the Moncrief Radiation oncology Department at the Simmons Cancer Center.
Primary objective: To escalate the dose of accelerated, hypofractionated, image-guided conformal radiotherapy to a potent tumorcidal dose without exceeding the maximum tolerated dose in treatment of stage ii-iV nSCLC in patients with poor performance status.
Secondary objectives: To evaluate local regional tumor control and overall survival in patients with stage ii-iV nSCLC and poor performance status treated with accelerated, hypofractionated, image-guided conformal radiotherapy.
Schema
number of patients between 7-45 (depending on tolerance)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must be willing and capable to provide informed consent to participate in the protocol.
- •Patients must have appropriate staging studies identifying them as AJCC stage II, III or IV non small cell lung cancer, [according to AJCC Staging, 6th edition; see appendix III], or recurrent non small cell lung cancer. Histologic confirmation of cancer will be required by biopsy or cytology.
- •Patients must have the potential for benefit from local therapy (at the discretion of the investigator).
- •Patient must have a Zubrod performance status of 2 or greater Or Patient must have had >10% weight loss in the past 6 months Or Patient is not eligible for concurrent chemoradiation as determined by a Medical Oncologist and Radiation Oncologist
- •The tumor must be ineligible for definitive surgical resection.
- •The tumor must be ineligible for stereotactic body radiation therapy.
- •Patients must have measurable or evaluable disease.
- •Women of childbearing potential and male participants must agree to use an effective method of contraception.
- •Patients must sign study specific informed consent prior to study entry.
- •Patients must complete all required pretreatment evaluations
排除标准
- •Evidence of small cell histology.
- •Tumor eligible for definitive surgical resection.
- •Tumor eligible for definitive stereotactic body radiation therapy.
- •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- •Chemotherapy given within one week of study registration.
- •Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
结局指标
主要结局
Number of Participants With Dose Limiting Toxicity
时间窗: 90 days after start of treatment up to 1 year
A dose limiting toxicity (DLT) is defined as treatment-related (definitely and probably, but not possibly related to treatment\*) grade 3 adverse events (per CTCAE, v.3.0, with the exception of pulmonary function tests)
次要结局
- Number of Participants With Local Regional Tumor Control at 16 Months(16 months)
- Number of Participants With Local Regional Tumor Control at 20 Months(20 months)
- Overall Survival at 6 Months(6 months)
- Number of Participants With Local Regional Tumor Control at 12 Months(12 months)
- Number of Participants With Local Regional Tumor Control at 3 Months(3 months)
- Number of Participants With Local Regional Tumor Control at 6 Months(6 months)
- Number of Participants With Local Regional Tumor Control at 9 Months(9 months)
研究者
Robert Timmerman
PROFESSOR
University of Texas Southwestern Medical Center