Clinical Trial TitleA randomized phase II/III trial of de-intensified radiation therapy for patients with early-stage, P16-positive, non-smoking associated oropharyngeal cancer.
Clinical Trial Protocol Description:
This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with HPV-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and is not associated with smoking. Radiation therapy uses high-energy X-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Nivolumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have pathologically proven diagnosis of squamous cell carcinoma of the oropharynx.
- Have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
- Have P16-positive based on local site immunohistochemical tissue staining.
- Provide personal smoking history prior to registration. The lifetime cumulative history cannot exceed 10 pack-years ((number of cigarettes per day x years of cigarette smoking) / 20)
This is a partial list of inclusion and exclusion criteria.