Isotoxic Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 7
- 主要终点
- The number of participants treated with isotoxic RT (to dose >60 Gy EQD2) using IMRT & hyperfractionated accelerated RT.
研究概览
简要总结
This study is for patients having a course of chest radiotherapy treatment after receiving chemotherapy for the treatment of non-small cell lung cancer. Patients with non-small cell lung cancer have a risk of the tumour in the lung recurring or progressing after treatment.
In this study, we will investigate:
- whether giving a more targeted and individualised type of chest irradiation or radiotherapy to the lung tumour (known as Isotoxic IMRT), is practical and whether it causes side effects which can be tolerated
- whether this new method of delivering the radiotherapy can reduce the risk of the tumour in the lung recurring or progressing
- whether survival can be improved by using this new radiotherapy method
The dose of chest irradiation will be calculated specifically to suit patient's body shape, the position of the lung cancer, and how close healthy tissues are to the tumour. Radiotherapy will be delivered twice a day over a maximum period of 4.5 weeks. The duration of treatment will vary individually according to the delivered dose to the tumour area.
详细描述
Background:
Approximately 12,000 patients are diagnosed with stage III NSCLC in the UK each year and their survival is ~15% at 5 years. As the majority of patients are not suitable for the gold standard treatment (concurrent chemo-radiotherapy (CTRT), novel strategies integrating radiotherapy (RT) technological advances and radiobiological knowledge need to be evaluated in patients treated with the alternative treatment option, sequential CTRT. There is solid evidence that improving local control in lung cancer leads to increased survival. Strategies to improve local control in stage III NSCLC include dose escalation and individualisation which are limited by the dose delivered to surrounding normal tissues. We hypothesise that this will be facilitated by the use of IMRT.
Objectives:
To demonstrate the feasibility of delivering isotoxic RT using IMRT and hyperfractionated accelerated RT in stage III NSCLC patients who are not suitable for concurrent CTRT.
Endpoints:
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
- •Histologically or cytologically confirmed NSCLC
- •Inoperable Stage III disease (T3N1-3, any T4, any N2 -3) confirmed by PET scanning, mediastinoscopy or thoracoscopy
- •Patients treated with at least 2 cycles of platinum based induction chemotherapy and able to start radiotherapy within 5 weeks of the last cycle of chemotherapy
- •Tumour judged inoperable by a lung MDT
- •Age 18+, no upper age limit
- •Performance status (PS) - ECOG 0-
- •Patients with PS 2 whose general condition is explained by disease can be included at the discretion of the local investigator. Patients with PS 2 as a result of co-morbid conditions will be excluded
- •Patient considered suitable for radical RT
- •Tumour that can be encompassed within a radical RT treatment volume (MLD expected to be <20Gy)
排除标准
- •Patients suitable for standard concurrent CTRT
- •Patients only suitable for radical RT due to PS and co-morbidities
研究组 & 干预措施
Thoracic radiotherapy
Intensity Modulated Radiotherapy treatment (delivered twice daily on consecutive weekdays over 4.5 weeks)
干预措施: Intensity Modulated Radiotherapy treatment (Radiation)
结局指标
主要结局
The number of participants treated with isotoxic RT (to dose >60 Gy EQD2) using IMRT & hyperfractionated accelerated RT.
时间窗: Stage 1 (12 months) - after 19 patients have been treated with isotoxic IMRT
Radiotherapy treatment plans \& OAR tolerance doses will be analysed to assess the feasibility of delivering the proposed treatment.
次要结局
- The number of participants from the study population who are suitable to receive isotoxic IMRT treatment.(12 months)
- The number of participants treated with isotoxic IMRT who experience grade 3+ pulmonary toxicity(12 months)
- The number of participants treated with isotoxic IMRT who experience acute grade 3+ non haematological toxicity & other late toxicities(12 months)
- Number of participants whose disease is controlled locally & overall survival rates(Follow up visits every 4 months for 2 years & then 6 monthly for up to 5 years)
研究者
Prof Corinne Faivre-Finn
Prof Corinne Faivre-Finn, Consultant Clinical Oncologist
The Christie NHS Foundation Trust