DAHANCA Proton Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 63
- 试验地点
- 7
- 主要终点
- Dysphagia >= grade 2
研究概览
简要总结
A study to investigate feasibility of local selection of patients with squamous cell carcinoma of the pharynx or larynx using anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia.
详细描述
In preparation for a randomised study in Denmark (DAHANCA 35) the feasibility of selecting newly diagnosed patients with squamous cell carcinoma of the pharynx or larynx for proton therapy at the local treatment centers is investigated. A proton and a photon doseplan is prepared for patients planned for primary radiotherapy . If proton radiotherapy reduces the anticipated absolute risk of dysphagia >= grade 2 (DAHANCA scale and/or xerostomia >= grade 2 (EORTC Head-Neck 35) with a clinical relevant value the patient is offered proton therapy at the Danish Center for Particle Therapy. The anticipated risk of xerostomia and dysphagia is estimated using Normal-Tissue Complication Models (NTCP).
At least five patients from each of the six Danish centers are required in this feasibility study.
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
- •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 2 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, nasopharynx, unknown primary tumor and prior malignancies.
- •Patients with contraindications for proton therapy (as per 2019 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 2
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
- EORTC C30(Up to five years after end of radiotherapy])
- Overall survival(Up to five years after end of radiotherapy])
- Time from referral to treatment(From date of referral to proton treatment to first proton treatment (Assessed up to 60 days))
- Acute toxicity(From the beginning of and up to two months after end of radiotherapy])
- Late toxicity(From two months to five years after end of radiotherapy])
- Loco-regional tumor control(Up to five years after end of radiotherapy)
- EORTC QLQ-Head-Neck 35(Up to five years after end of radiotherapy)