Functional Lung Avoidance SPECT-guided (ASPECT) Radiation Therapy for Lung Cancer Patients: Phase II Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Radiation-induced lung toxicity
研究概览
简要总结
Study aims to determine if functional lung avoidance based on perfusion single photon emission (SPECT)/CT scan, improves toxicity outcomes for patients with advanced lung cancer undergoing chemo-radiotherapy. Functional avoidance implies a dose plan that takes functional distribution in the lung into account, and avoids highly functional lung volumes sparing them from radiation.
详细描述
In this project, a novel method of safe radiotherapy delivery shall be tested for patients with lung cancer in a clinical setting. Functional avoidance radiotherapy is a new method that protect highly functional lung tissue from radiation, while delivering high dose radiotherapy to the lung tumour. Radiotherapy is usually based on a CT scan that does not account for functional variations in the lungs. Therefore, I hypothesize that using functional distribution in the lungs and avoiding irradiation of highly functional lung will improve treatment outcome for individual patients with lung cancer.
The objective of my project is to determine if functional image guided radiotherapy (functional avoidance radiotherapy) improves toxicity outcomes for patients with lung cancer undergoing curative chemo-radiotherapy in a prospective clinical trial.
To reach this objective, the impact of functional avoidance radiotherapy on pulmonary toxicity measured by the incidence and severity of radiation-induced lung disease shall be assessed. Additionally, loco-regional control, time to progression, overall survival, quality of life and radiation-induced molecular response in patients treated with functional avoidance radiotherapy shall be assessed and compared to patients receiving standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, care providers and outcome assessors are blinded
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
- •histologically verified lung cancer (small-cell and non-small cell lung cancer)
- •referred for radiotherapy with curative intent
- •radiation dose of 60-66 Gy given in 2-Gy fractions, other dose levels and fractionation schedules accepted, as per site standard
- •concurrent chemotherapy is accepted
- •patients with oligometastatic disease are allowed, where metastasis have been ablated with surgery or radiotherapy
- •receiving (chemo)-radiotherapy to the thoracic disease with curative intent
- •adults over 18, that have given oral and written informed consent before patient registration.
排除标准
- •concurrent immunotherapy
- •previous radiotherapy to the thorax
- •other uncontrolled malignancies; any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
研究组 & 干预措施
SPECT functional avoidance treatment
SPECT-based radiation therapy given taken functional distribution in the lung into account, that avoids highly functional lung volumes sparing them from radiation.
干预措施: Single-photon-emission CT scan (Diagnostic Test)
Standard treatment
CT-based radiation therapy given over 5- 6.5 weeks.
结局指标
主要结局
Radiation-induced lung toxicity
时间窗: Measured serially from 1 to 12 months after treatment completion
crude rate of symptomatic radiation-induced lung toxicity of grade 2 and higher. According to the Common Toxicity Criteria for Adverse Events version 5.0 for radiation pneumonitis, dyspnea, cough, or any other radiation-induced respiratory, thoracic and mediastinal disorder.
次要结局
- Overall survival(at 12 months)
- Quality of life(Measured serially from 1 to 12 months after treatment completion)
- Patient reported lung symptoms(Measured serially from 1 to 12 months after treatment completion)
- Progression-free survival(at 12 months)
- Loco-regional control rate(at 12 months)
研究者
Katherina Farr, MD, PhD
Specialist in Clinical Oncology
Aarhus University Hospital