DAHANCA 35: A Randomized Trial of Proton Versus Photon Radiotherapy for the Treatment of Head-neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 7
- 主要终点
- Dysphagia >= grade 2
研究概览
简要总结
Patients with squamous cell carcinoma of the pharynx or larynx and an anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia are randomized to proton or photon radiotherapy (2:1)
详细描述
DAHANCA 35 is two parallel conducted, but separate randomized studies, within the same trial (DAHANCA 35D and DAHANCA 35X) by the Danish Head-Neck Cancer Study Group (DAHANCA). In patients with squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy a proton and a photon doseplan is prepared. If proton radiotherapy reduces the anticipated absolute risk of dysphagia >= grade 2 (DAHANCA scale, DAHANCA 35D) or severe xerostomia >= grade 4 (EORTC Head-Neck 35, DAHANCA 35X) more than 5%, the patient is randomised to either proton therapy or photon therapy, 2:1. The anticipated risk of xerostomia and dysphagia is estimated using Normal-Tissue Complication Models (NTCP). Patient are analysed according to the primary endpoint (dysphagia and/or xerostomia) after which they were enrolled. DAHANCA 35D is expected to enroll 360 patients and DAHANCA 35X 240 patients (in total 600 patients).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy with curative intent
- •A predicted clinical significant reduction in the risk of any of the two primary endpoints (>= grade 2 observer-rated dysphagia or grade 4 patient-reported xerostomia) after proton therapy compared to photon therapy based on comparison of the individual patient dose plans
- •No current or earlier malignancies, which may influence treatment, evaluation or outcome of the head-neck cancer
- •Informed consent as required by law
- •Above 18 years of age
排除标准
- •Patient with cancers of the glottic larynx (stage I/II), skull base, sino-nasal area, unknown primary tumor and prior malignancies.
- •Patients with contraindications for proton therapy. Per October 2020, this includes pacemakers, implanted defibrillators and tracheostomy
- •Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
- •Distant metastasis
- •Previous radiotherapy of the head and neck
- •Previous surgery for the primary cancer with curative intent
结局指标
主要结局
Dysphagia >= grade 2
时间窗: Six months after end of radiotherapy
The rate of observer-reported dysphagia \>= grade 2 measured by the DAHANCA late toxicity score (grade 0-4, with 0 being best)
Xerostomia = grade 4
时间窗: Six months after end of radiotherapy
The rate of patient-reported xerostomia measured by the EORTC Quality of life questionnaire (QLQ) Head-Neck (HN) 35 (grade 1-4, with 1 being best)
次要结局
- Loco-regional tumor control(Up to five years after end of radiotherapy)
- Disease-specific survival(Up to five years after end of radiotherapy)
- Late toxicity(From two months to five years after end of radiotherapy)
- Number of participants with disease-free survival(Up to five years after end of radiotherapy)
- EORTC C30(Up to ten years after end of radiotherapy)
- MD Anderson Dysphagia Index(Up to ten years after end of radiotherapy)
- Overall survival(Up to five years after end of radiotherapy)
- EORTC QLQ-Head-Neck 35(Up to ten years after end of radiotherapy)
- Stimulated whole-mouth salivary flow(Up to five years after end of radiotherapy)
- Acute toxicity(From the beginning of and up to two months after end of radiotherapy)
- Modified barium swallowing(One year after end of radiotherapy)
- EuroQol Five Dimension Scale (EQ-5D)(Up to ten years after end of radiotherapy)
- Composite time corrected toxicity score (CTCT)(Up to five years after end of radiotherapy)