Pilot Study: Testing the Feasibility of a Simplified Workflow for Lung Cancer Radiation Target Review With Radiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Number of Completed Radiation Treatment Plans Reviewed
研究概览
简要总结
The purpose of this research study is to see if adding an "extra" check by formal radiology review is possible without disrupting the normal processes that take place to develop and prepare a safe radiation treatment plan for patients.
详细描述
Primary Objectives: The primary objective will be to demonstrate the feasibility of radiology completing real time review of radiation oncology treatment plans within 4 business days of the date of CT simulation (defined as day = 0). If 50% of plans can be reviewed by any member of the thoracic radiology team (Includes radiology PI and co-investigators) and feedback is submitted to radiation oncology with Appendix D within 4 business days of the date of simulation, then we will consider this workflow feasible.
Secondary Objectives:
- Our primary secondary objective will be to estimate the proportion of patients whose RT plans are changed as a result this workflow.
- For patients whose radiation therapy plans are changed as a result this workflow, determine the absolute and percentage volume changes in the gross tumor volume, clinical target volume and planning target volume as a result of these changes implemented.
- For patients whose radiation therapy plans are changed as a result of this workflow: determine if recommended changes in the gross tumor volume resulted in improved dosimetry to surrounding normal structures. Specifically, determine the absolute and percentage changes in the dose delivered to the lungs (V5, V10, V20) and esophagus (mean, V60) as a result of changes in the gross tumor volume.
- For patients whose radiation therapy plans are changed as a result of this workflow, determine if changes led to treatment delays from their standard planned start date.
- For patients whose radiation therapy plans are changed as a result of this workflow, to describe the most common types of changes recommended (i.e. modification of parenchymal lung volumes, missing involved lymph nodes, covering too much normal tissue in the gross tumor volume).
- Determine whether acute esophagitis incidence changed in our entire sample as a result of this review during treatment and within 4 weeks following treatment, compared to institutional historical control databases of patients treated without formal radiology review.
- Determine whether tumor response at 4 weeks post treatment differs in our entire sample compared to institutional historical control databases of patients treated without formal radiology review.
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
- •Disease that is being treated as locally advanced non-small cell lung cancer (NSCLC) or limited stage small cell lung cancer (SCLC). Specifically, AJCC 8th edition staging with T3 or T4 and/or N1-3 disease. Patients with unclear pathology who are being treated clinically as non-small cell lung cancer or as limited stage small cell lung cancer are eligible.
- •Plan for radiotherapy to be delivered with curative intent per the treating radiation oncologist in the Wake Forest Baptist Comprehensive Cancer Center Department of Radiation Oncology.
排除标准
- •Not being treated with radiation, or being treated with non-curative intent per the treating radiation oncologist.
研究组 & 干预措施
Radiology Treatment Planning/Review
After patient consultation and enrollment, the patient will undergo routine CT simulation to initiate the radiation treatment planning process. The treating physician will contour the gross tumor volume (GTV) including the involved primary lung tumor and/or the involved lymph nodes. If the initial radiology review reflects concern for inadequate target volume delineation, the case will be flagged for multidisciplinary discussion between the radiation oncologist and radiologist.
干预措施: CT Simulation (Procedure)
结局指标
主要结局
Number of Completed Radiation Treatment Plans Reviewed
时间窗: Within four days after CT simulation
Completed initial radiology review within 4 business days after the date of CT simulation will be calculated using summary statistics including count (frequency) using a 95% confidence interval.
次要结局
- Number of Patients with Acute Esophagitis(4 weeks after completion of therapy)
- Number of Patients Whose Radiation Treatment Plans Changed(4 days)
- Changes in Volumes After Radiation Treatment Changes - Clinical Tumor Volume(4 days)
- Number of Patients Who's Treatment Starts are Delayed(4 days)
- Number of Changes Recommended by the Radiation Therapy Quality Assurance Conference (RT QAC)(4 days)
- Changes in Volumes After Radiation Treatment Changes - Gross Tumor Volume(4 days)
- Changes in Volumes After Radiation Treatment Changes - Planning Tumor Volume(4 days)
- Changes in Dose Delivered After Radiation Treatment Changes to the Lungs(4 days)
- Cancer Response(1 month after completion of therapy)
- Changes in Dose Delivered After Radiation Treatment Changes to the Esophagus(4 days)