NCT04220749招募中2 期
A Phase II Randomized Trial for HPV-Negative Oropharyngeal Squamous Cell Carcinoma: Radiotherapy vs. Trans-Oral Surgery (ORATOR)
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年6月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Disease-Specific Survival
研究概览
简要总结
The goal of this randomized phase II study is a formal comparison of radiotherapy versus trans-oral surgery as the primary treatment of HPV-negative patients with early-stage oropharyngeal carcinoma.
详细描述
This study is designed as a randomized phase II study. Patients will be randomized between current standard of care treatment (Arm 1) vs. TOS (Arm 2) in a 1:1 ratio. Additionally, patients will be stratified according to T stage (T1 vs. T2); N stage (N0/1 vs. N2/3)
The randomized phase II design is required for three reasons:
- The randomization will provide an appropriate control group to serve as a comparator for the experimental arm. Historical or contemporaneous non-randomized controls would not be appropriate due to the multitude of biases that could be introduced by patient selection and other confounders.
- A small sample size will allow for adequate power to assess for progression-free survival, and also an assessment of quality of life, overall survival and toxicity.
- The results will allow for a decision as to whether a multi-institutional phase III trial is warranted, and inform the design of such a trial.
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
- •Age 18 years or older
- •Willing to provide informed consent
- •ECOG performance status 0-2
- •Histologically confirmed squamous cell carcinoma
- •HPV-negative tumor, as determined by: negative p16 status, real time PCR or in-situ hybridization. Central confirmation is not required prior to randomization. Equivocal/uncertain HPV status will be allowed on trial.
- •Primary tumor site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)
- •Tumor stage: T1 or T2, with likely negative resection margins at surgery
- •Nodal stage: N0-
- •Patients with positive nodal disease and extranodal extension on imaging may be included at the surgeon's discretion, if the nodal disease is deemed resectable by the operating surgeon.
- •Eligible for curative intent treatment, with likely negative resection margins at surgery. For patients where adequate transoral access is in question, they will first undergo an examination under anesthesia prior to randomization to ensure adequate exposure can be obtained.
- •Blood work obtained within 4 weeks prior to randomization, with adequate bone marrow function, hepatic, and renal function, as determined by the investigator.
- •Patient assessed by a radiation oncologist and surgeon and presented at multidisciplinary tumor board prior to randomization. If not feasible, case can be discussed with study Principal Investigator.
排除标准
- •Serious medical comorbidities or other contraindications to radiotherapy, chemotherapy or surgery
- •Prior history of head and neck cancer within 5 years
- •Prior head and neck radiation at any time
- •Metastatic disease
- •Inability to attend full course of radiotherapy or follow-up visits
- •Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer
- •Unable or unwilling to complete QOL questionnaires
- •Pregnant or lactating women
结局指标
主要结局
Disease-Specific Survival
时间窗: 5 years
Time from randomization to death from cancer
次要结局
- Feeding tube rate at 1 year(Baseline to 1 year post treatment)
- Progression-Free Survival(5 years)
- Distant Failure(5 years)
- CTCAE Dysphagia Grade(Baseline to 5 years post treatment)
- Local-Regional Failure(5 years)
- Toxicity profile of both study arms using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 4(Randomization until 5 years follow up)
- Overall Survival(5 years)
- Any Failure(5 years)
- Quality of Life(Baseline to 5 years follow up)
研究者
研究点 (2)
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