Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects: A Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 14
- 主要终点
- Regional failure in the pN0 hemi-neck (s)
研究概览
简要总结
The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options.
详细描述
The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options.
The study will require a sample size of 90 patients randomized in a 2:3 between the two arms. Arm 1 (standard radiation therapy to tumor location and surrounding area) and Arm 2 (targeted radiation therapy to tumor location).
Patients will be followed for a total of 5 years.
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
- •Willing to provide informed consent
- •ECOG performance status 0-2
- •Histologically confirmed, resected oral cavity squamous cell carcinoma with at least ipsilateral selective neck disection
- •Patient has pathological features that are indications for PORT: positive or close (≤ 3 mm) margin, presence of LVI or PNU, pT3 or pT4 disease, positive lymph nodes, and PORT is recommended by treating physician
- •Pathologically lympth node negative in at least one dissected hemi-neck with at least 10 nodes recovered in each pN0 hemi-neck
排除标准
- •Serious medical comorbidities or other contraindications to radiotherapy
- •Prior history of head and neck cancer within 5 years
- •Any other active invasive malignancy, except non-melanotic skin cancers
- •Prior head and neck radiation at any time
- •Prior oncologic head and neck surgery in the oral cavity or neck
- •Metastatic disease
- •Locoregional disease recurrence identified following surgical resection but prior to the start of radiotherapy
- •Inability to attend full course of radio therapy or follow-up visits
- •Unable or unwilling to complete QoL questionnaires
- •Pregnant or lactating women
结局指标
主要结局
Regional failure in the pN0 hemi-neck (s)
时间窗: Baseline to 5 years
Rate of relapse in the pN0 neck in Arm 2 compared to historical controls
次要结局
- Locoregional recurrence(Baseline to 5 years)
- Local recurrence(Baseline to 5 years)
- Regional recurrence(Baseline to 5 years)
- Rate of salvage treatment (surgery +/- radiotherapy) in the pN0 neck and freedom from unsalvageable neck recurrence(Baseline 5 years)
- Rate of failure in the clinically node negative neck(Baseline to 5 years)
- Rate of feeding tub insertion and rate of feeding tube use at 1-year post randomization(Randomization to 1 year post randomization)
- Rate of toxicity(Baseline to 5 years)
- Health Status Quality of life(Baseline up to 12 months)
- Overall survival(Baseline to 5 years)
- Disease free survival(Baseline to 5 years)
- Swallowing Quality of life(Baseline up to 12 months)
- Swallowing function(Baseline to 1 year)