Phase II Clinical Trial of De-Intensified Therapy in Human Papilloma Virus (HPV) Associated Oropharyngeal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Assess oncologic outcomes of a de-intensified post-surgical adjuvant treatment by measuring overall survival.
研究概览
简要总结
HPV-associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) is a type of cancer that affects parts of the throat, like the tonsils and the base of the tongue. The treatments for OPSCC, which may include surgery, radiation, and chemotherapy, often cause serious side effects, such as loss of taste, dry mouth, and long-term problems with swallowing. These side effects can lower patients' quality of life and make it difficult for them to eat and speak normally.
This study aims to explore whether using lower doses of radiation after surgery can help improve long-term swallowing function in patients with HPV-positive OPSCC. By doing this, the study team hopes to reduce treatment-related side effects while maintaining good cancer control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 or suspected HPV associated squamous cell carcinoma of the oropharynx.
- •p16 immunohistochemistry is the surrogate marker for HPV positivity and will be scored as positive if there is strong and diffuse nuclear and cytoplasmic staining present in greater than 70% of the tumor specimen. (A negative result excludes the patient from the trial)
- •In the case of equivocal p16, High Risk HPV (HR HPV), In-Situ Hybridization (ISH) / Polymerase Chain Reaction (PCR) may be performed to determine HPV positivity
- •AJCC TNM 7th edition stage T1-T3, N0-N2b (or AJCC TNM 8th edition stage T1-T3 N0-N1) disease.
- •Staging will be based on cross sectional imaging investigations and clinical exam.
- •Patients who initially have an unknown primary but subsequently have a primary site identified on pathology after surgical resection may be included in the study.
- •Multidisciplinary team decision to treat with primary transoral resection and neck dissection.
- •Patients considered fit for surgery and adjuvant therapy.
- •Aged 18 or over.
- •Written informed consent provided.
排除标准
- •HPV negative squamous cell carcinomas of the head and neck
- •T4 and/or T1-T3 tumors where transoral surgery is considered not feasible or there is a high likelihood of positive margins.
- •AJCC TNM 7th edition N2c-N3 nodal disease (or AJCC TNM 8th edition N2-N3 nodal disease) or high likelihood of gross extranodal extension.
- •Patients for whom transoral surgery and neck dissection is not considered the primary treatment modality.
- •Distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g. CT thorax and upper abdomen or PET CT.
- •Women who are pregnant or breastfeeding
- •Prior history of radiation to head and neck
结局指标
主要结局
Assess oncologic outcomes of a de-intensified post-surgical adjuvant treatment by measuring overall survival.
时间窗: from enrollment to 5 year follow-up
Overall survival will be monitored.
Safety and tolerability
时间窗: from enrollment to 5 year follow-up
The study will use the CTCAE version 5.0 for reporting of non-hematologic adverse events.
Assess oncologic outcomes of a de-intensified post-surgical adjuvant treatment by measuring progression free survival.
时间窗: from enrollment to 5 year follow-up
Assess oncologic outcomes of a de-intensified post-surgical adjuvant treatment by measuring progression free survival.
Assess oncologic outcomes of a de-intensified post-surgical adjuvant treatment by measuring locoregional control.
时间窗: from enrollment to 5 year follow-up
Locoregional control (LRC) is defined as time from treatment initiation to local or regional recurrence
次要结局
- Evaluate how changes in serum HPV ctDNA are associated\ with HPV-positive OPSCC recurrence(from enrollment to 5 year follow-up)
研究者
Mirabelle Sajisevi
Associate Professor, Division of Otolaryngology - Head & Neck Surgery
University of Vermont Medical Center