Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark
DAHANCA Proton Feasibility Study
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Aalborg、丹麦
- Aalborg University Hospital
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Aarhus、丹麦
- Aarhus University Hospital
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Aarhus、丹麦
- Danish Center for Particle Therapy
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Copenhagen、丹麦
- Rigshospitalet
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Herlev、丹麦
- Herlev Hospital
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Næstved、丹麦
- Næstved Hospital
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Odense、丹麦
- Odense University Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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
Exclusion Criteria:
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Proton radiotherapy
Proton radiotherapy according to the guidelines defined by the Danish Head-Neck Cancer Group (DAHANCA).
Treatment: 66-68 Gy/ 33-34 fx/ 6/W,with cisplatin 40 mg/m2/W and nimorazole to suitable patients
|
Proton radiotherapy according to the guidelines defined by the Danish Head-Neck Cancer Group (DAHANCA).
Treatment: 66-68 Gy/ 33-34 fx/ 6/W, with cisplatin 40 mg/m2/W and nimorazole to suitable patients
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
吞咽困难 >= 2 级
大体时间：放疗结束后六个月
|
根据 DAHANCA 晚期毒性评分（0-4 级，0 级最好）测量的观察者报告的吞咽困难发生率 >= 2 级
|
放疗结束后六个月
|
|
Xerostomia = grade 2
大体时间：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)
|
Six months after end of radiotherapy
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Loco-regional tumor control
大体时间：Up to five years after end of radiotherapy
|
Time to event of local-regional failure, from date of randomization to the date of first documented loco-regional failure. Rates are estimated by the Kaplan-Meier method. Interim analyses after 100, 200 and 300 patients. Will not be reported before the primary endpoint. |
Up to five years after end of radiotherapy
|
|
Overall survival
大体时间：Up to five years after end of radiotherapy]
|
From date of randomisation to date of death
|
Up to five years after end of radiotherapy]
|
|
Acute toxicity
大体时间：From the beginning of and up to two months after end of radiotherapy]
|
DAHANCA acute toxicity score (grade 0-4, 0 being best)
|
From the beginning of and up to two months after end of radiotherapy]
|
|
Late toxicity
大体时间：From two months to five years after end of radiotherapy]
|
DAHANCA late toxicity score (grade 0-4, 0 being best)
|
From two months to five years after end of radiotherapy]
|
|
EORTC QLQ-Head-Neck 35
大体时间：Up to five years after end of radiotherapy
|
Swallowing and social-eating scale and specific HN35 items related to eating and pain (grade 1-4, 1 being best)
|
Up to five years after end of radiotherapy
|
|
EORTC C30
大体时间：Up to five years after end of radiotherapy]
|
Specific C30 items related to fatigue, nausea and vomiting (grade 1-4, 1 being best)
|
Up to five years after end of radiotherapy]
|
|
Time from referral to treatment
大体时间：From date of referral to proton treatment to first proton treatment (Assessed up to 60 days)
|
Time from referral to proton center to first proton treatment
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From date of referral to proton treatment to first proton treatment (Assessed up to 60 days)
|
合作者和调查者
调查人员
- 首席研究员：Jeppe Friborg, MD, PhD、Danish Head-Neck Cancer Group (DAHANCA)
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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