Proton Therapy to Reduce Acute Normal Tissue Toxicity in Locally Advanced Non-small-cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Occurrence of acute and intermediate radiation induced side effects
研究概览
简要总结
The aims of the study are to reduce acute radiation induced side effects, i.e. pneumonitis and esophagitis grade II or higher by the use of proton therapy compared to photon radiotherapy of equal total dose. Secondary endpoints include evaluation of quality of life, loco-regional control, survival and late radiation induced side effects.
详细描述
Patients in this trial undergo primary radiochemotherapy for locally advanced NSCLC. As early and intermediate late effects of radiotherapy do not only hamper quality of life but can, in the case of radiation induced pneumonitis, be potentially lethal, a reduction of these side effects is desirable. Patients in this trial are 1:1 randomised to intensity modulated radiotherapy with photons or proton therapy. The primary aim of the study is to show a decrease of pneumonitis and or esophagitis grade 2 or higher by proton therapy. The observed incidence of both these side effects is 39% with photon therapy. The estimated incidence with proton therapy is around 12 %. Simultaneous chemotherapy will be applied to current clinical standards.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSCLC (confirmed by cytology or histology) staged UICC IIIA or IIIB or UICC II if the patient declines surgery
- •no distant metastases (M1)
- •patient' age between 18 and 70 years
- •Patient medically suited for primary radiochemotherapy with curative intent
- •signed declaration of informed consent
- •adequate compliance for treatment and clinical follow up
- •adequate contraception during and after therapy if indicated
排除标准
- •Participation in other interventional trial
- •T1 or T2 N0 tumours that are candidates for stereotactic radiotherapy
- •relevant neurological or psychiatric disorders that hinder treatment, follow-up or understanding of the procedures
- •pregnant or breastfeeding women
- •prior thoracic radiotherapy
- •history of other malignancies during the last 5 years (exceptions can be made for tumours with excellent outcome)
- •weight loss greater than 15% before therapy
- •serological alterations (liver, kidney) prohibiting application of simultaneous chemotherapy
- •respiratory motion of the tumour > 10 mm (evaluated by 4D CT), also when methods for motion reduction (abdominal compression) are used
研究组 & 干预措施
Proton therapy
Patients within the proton arm will receive 66 Gy(RBE) delivered with 6 fractions per week.
干预措施: Proton therapy (Radiation)
Photon therapy
Patients within the photon arm will be treated by intensity modulated radiotherapy with 6 fractions per week to a total dose of 66 Gy.
干预措施: Photon therapy (Radiation)
结局指标
主要结局
Occurrence of acute and intermediate radiation induced side effects
时间窗: no later than six months after end of treatment
次要结局
未报告次要终点
研究者
Prof. Esther Troost
Prof. Esther Troost
Technische Universität Dresden