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.
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 tumor for biopsy/sample or symptom alleviation will be permitted, as long as gross unresected tumor is left behind.
Subjects must agree to biopsy of areas that are FDG-avid on PET-CT scan 3-4 months after treatment.
Patients with gross involvement of level 4 lymph node level
Endophytic T3 disease, as clinically determined by the principal investigator.
Patients with any single lymph node > 4cm (multiple lymph nodes including nodal conglomerates that in sum measure >4cm is allowed)
Patients with nodal disease clinically fixed to or radiographically invading adjacent neck musculature any single lymph node > 4cm (multiple lymph nodes including nodal conglomerates that in sum measure >4cm is allowed)
Single group
Radiation
RadiationRadiation only to 66Gy
Progression Free Survival (PFS)
Progression Free Survival- 2-year progression free survival, as determined by standard of care physical examination and standard of care surveillance imaging.
Local Control of disease (LC) rate
Number of patient with local control at 2 years, as determined by standard of care physical examination and/or standard of care surveillance imaging.
Regional Control of diseaes (RC) rate
Number of patient with regional control at 2 years, as determined by standard of care physical examination and/or standard of care surveillance imaging.
Distant Metastasis-Free Survival (DMFS) rate
Distant Metastasis-Free Survival as determined by standard of care physical examination and standard of care surveillance imaging at 2 years.
Overall Survival (OS)
Defined a time from start of treatment until end of study or death.
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