NCT06641791招募中3 期
A Phase III Randomized Controlled Trial Comparing Palliative Stereotactic Body Radiotherapy vs. Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 196
- 试验地点
- 11
- 主要终点
- Overall Survival estimated according to Kaplan-Meier's methodology
研究概览
简要总结
This study is being done to answer the following question: Does stereotactic body radiation therapy (SBRT) provide better cancer control compared to standard radiation therapy (RT) for those with advanced head and neck cancer?
详细描述
Stereotactic body radiation therapy, or SBRT, is a cancer treatment that more precisely delivers radiation to the tumour area with less radiation going to unaffected areas around the tumour. It uses fewer treatments of higher doses compared to standard radiation therapy.
This study is being done to find out if this approach is better than the usual approach for advanced head and neck cancer. The usual approach is defined as care most people get for advanced head and neck cancer.
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
- •Histologically confirmed mucosal squamous cell carcinoma (SCC) of the head and neck arising from at least one of the following sites: oro/hypopharynx, oral cavity, supraglottic larynx, maxillary sinus, nasal cavity, or unknown primary
- •Stages TX or T0-T4/N0-N3
- •Must be considered unfit for curative intent RT as determined by the treating oncologist(s)
- •Geriatric 8 score <14
- •Patient must be ≥18 years of age
- •Staging CT or MRI of the head and neck within 8 weeks prior to randomization
- •Chest CT or x-ray. PET CT is permitted if CT is of diagnostic quality.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
- •Participants of childbearing potential must have agreed to use a highly effective contraceptive method during protocol therapy.
- •Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational treatment are eligible for this trial.
排除标准
- •Patients with nasopharyngeal carcinoma.
- •Prior systemic therapy (including immunotherapy).
- •Prior radiotherapy to the head and neck excluding superficial radiotherapy for head and neck skin cancer that does not overlap with current protocol treatment.
- •Prior head and neck cancer excluding skin cancer.
- •Patients with tumour locations/at risk of SBRT toxicity, including glottic/subglottic larynx, T4 hypopharynx, post-cricoid, cervical esophagus, circumferential pharyngeal involvement, extension/proximity to brain/optic structures, any single tumour mass >8 cm (in one dimension).
- •> 2 nodal levels (Level 1a/b not counted); retropharyngeal lymph nodes (where the closest edge is < 2cm from the closest edge of CTV (primary or nodal) will not be considered as a different level). Note: a single lymph node mass that spans 2 levels will be considered as 1 level.
- •Gross tumour poorly visualized on CT/MRI.
- •Definitive radiological or clinically evident distant metastases.
- •Scleroderma/CREST syndrome.
研究组 & 干预措施
Stereotactic Body Radioterapy (SBRT)
Experimental
干预措施: Stereotactic Body Radiotherapy (SBRT) (Radiation)
Standard Radiotherapy (SRT)
Active Comparator
干预措施: Standard Radiotherapy (SRT) (Radiation)
结局指标
主要结局
Overall Survival estimated according to Kaplan-Meier's methodology
时间窗: 6 years
次要结局
- Response Rate evaluated by RECIST(6 years)
- Number and Severity of Adverse Events(6 years)
- Patient Reported Outcomes utilizing PRO-CTCAE(6 years)
- Patient Reported Outcomes utilizing FACT-HN(6 years)
- Healthcare Resource Utilization utilizing EQ-5D-5L(6 years)
- Progression-free Survival(6 years)
- Local Regional Failure Free Survival(6 years)
研究者
研究点 (11)
Loading locations...
相似试验
招募中
3 期
Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone MetastasesCancer MetastaticNCT06391242Canadian Cancer Trials Group230
已完成
不适用
Randomized Trial Comparing Conventional Radiotherapy With Stereotactic Radiotherapy in Patients With Bone Metastases - VERTICAL StudySpinal MetastasesBone MetastasesNCT02364115UMC Utrecht110
招募中
不适用
SBRT Versus Ablation for Perivascular Hepatocellular CarcinomaHepatocellular CarcinomaNCT04434989Sun Yat-sen University170
招募中
3 期
Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung CancerLocally Advanced Lung Non-Small Cell CarcinomaStage IIB Lung Cancer AJCC v8Stage III Lung Cancer AJCC v8NCT05624996NRG Oncology474
终止
3 期
Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)Non-Small Cell Lung CancerNCT03924869Merck Sharp & Dohme LLC448