Role of SPECT in Radiotherapy Treatment Planning and Toxicity Evaluation for the Patients With Stage I-III NSCLC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Grade 2 radiation pneumonitis
研究概览
简要总结
Overall objective of the study is to compare the use of SPECT in radiotherapy treatment planning with standard CT-based radiotherapy for stage I-III non-small-cell lung cancer patients
详细描述
Primary objective:
-To compare the rate of grade 2 or higher pneumonitis amongst patients with stage III NSCLC treated with radiotherapy using SPECT in radiotherapy treatment planning versus standard CT-based radiotherapy planning;
Secondary Objectives:
- To evaluate SPECT as a tool to predict lung toxicity;
- To establish estimates for the incidence and severity of pulmonary tissue effects observed in stage III NSCLC patients treated with radiotherapy;
- To generate hypotheses for subsequent use of SPECT-CT-based treatment planning as a method for minimization of toxicity risks
- To generate hypotheses for modeling studies of SPECT-CT-based treatment planning for dose-escalation;
- To compare the loco-regional control, time to progression and overall survival of patients treated with SPECT-based plan versus standard CT-based plan
- To compare the quality of life in patients randomized to the two study arms.
This trial is a single centre observational study. All patients will irrespective of their registration in the trial receive radiotherapy according to the standard treatment regimen at the Department of Oncology, Aarhus University Hospital. Participation implies baseline and follow-up procedures. In the treatment planning phase patients will be randomized to one of the following arms: Arm 1 SPECT/CT-based treatment plan with functional dose-volume parameters and Arrm 2 Standard CT-based plan with conventional dose-volume parameters.
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
- •Stage I-III non-small cell lung cancer, histologically verified
- •Referred for definitive radiotherapy to the Department of Oncology, Aarhus University Hospital
- •Meet the criteria for curatively intended radiotherapy described in details in the national guidelines
- •Concurrent chemotherapy is accepted
- •Adults over 18, that have given oral and written informed consent before patient registration
- •The patients can only be randomized in this trial once
排除标准
- •other uncontrolled malignancies
- •human albumin allergy
- •any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
研究组 & 干预措施
Arm 1
SPECT scan will be performed at baseline. Patients will receive radiotherapy according to standard CT-based plan with conventional dose-volume histogram
干预措施: SPECT-based treatment plan (Other)
结局指标
主要结局
Grade 2 radiation pneumonitis
时间窗: measured 0-12 months after completed radiotherapy
The primary endpoint is grade 2 pneumonitis, defined according to the NCI Common Toxicity Criteria for Adverse Events (CTC) version 4.0. Estimation of the occurrence of pulmonary tissue effects: Number of patients developing pulmonary toxicity over grade 2 in both treatment arms according to the Common Terminology Criteria for Adverse Events CTC v. 4.0 and measured serially from 0 to 12 months after radiotherapy, as well as according to the SOMA-LENT scale measured serially from 0 to 12 months after radiotherapy
次要结局
- Mean lung dose (MLD) and V5-50(volume of the lung receiving 5-50 Gy or more)(12 months after radiotherapy)
- Overall quality of life score(0-12 months after radiotherapy)
- Progression-free survival(at 12 months after radiotherapy)
研究者
Katherina Farr
Principle Investigator
University of Aarhus