A Phase II Study of Treatment De-Escalation for Favorable Prognosis, Stage I-II Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy
Georgetown University
Summary
The current standard treatment option for Human Papillomavirus (HPV) or p16-positive oropharyngeal cancer is full-dose radiation combined with chemotherapy. Results with chemotherapy combined with full-dose radiation therapy leads to high rates of cure; this has called into question whether therapy can be decreased in intensity since both chemotherapy and radiation have long-term side effects. One approach to decrease intensity of treatment is to give radiation alone (excluding chemotherapy) and to decrease radiation therapy dose. The investigator believes that omitting chemotherapy and decreasing radiation dose both to tumor and the regions of the head and neck at highest risk of potential spread, may have no significant impact on the cancer recurring while potentially leading to fewer long-term side effects.
Description
This study aims to estimate the efficacy of radiation dose de-escalation while omitting chemotherapy for favorable prognosis HPV or p16-positive oropharyngeal cancer patients receiving definitive radiation therapy, where efficacy is measured by 2-year progression free survival (PFS) rate after treatment de-escalation for low-risk HPV+ oropharyngeal squamous cell carcinoma. This study also aims to determine quality of life parameters, complete clinical and radiographic response, as well as local, regional and distant metastasis control as well as overall survival.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must be ≥ 18 years of age on the day of signing informed consent. * Patients must have a diagnosis of p16+ and/or HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus, tonsil, soft palate, vallecula, and/or posterior oropharyngeal wall). * clinical stage stage I-II (T1-2 N1 M0, or T3 N0-1 M0 ) (AJCC 8th ed.) SCCA of the oropharynx that would mandate definitive chemoradiation as current standard of care when standard radiation fractionation is applied. Debulking of the disease by resecting the exophytic portion of the tu…
Interventions
- RadiationRadiation
Radiation only to 66Gy
Locations (2)
- Medstar Georgetown University HospitalWashington D.C., District of Columbia
- Medstar Southern Maryland Hospital CenterClinton, Maryland