Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-pos
This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized
| Condition(s) | Cancer of the Head and Neck, Oropharynx Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Throat Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment. |
| Who can participate | Inclusion Criteria: * Patients generally must have the psychological ability and general health that permits completion of the study requirements and required follow up. * Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until at least 60 days following the last study treatment. * Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evide |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Missouri-Columbia |
| Locations | Columbia, Missouri, United States |
| Start date | 2020-09-28 |
| NCT ID | NCT04444869 |
| Official listing | https://clinicaltrials.gov/study/NCT04444869 |