De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study

Inclusion Criteria

• •1. ≥ 18 years of age (no upper age limit)
• •2. T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx
• •3. Biopsy proven squamous cell carcinoma that is HPV and/or p16 positive
• •4. ≤ 10 pack-years smoking history or ≤ 30 pack-years smoking history WITH ≥ 5 years abstinence from smoking
• •5. Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to treatment
• •6. ECOG Performance Status 0-1
• •7. CBC/differential obtained within 8 weeks prior to treatment, with adequate bone marrow function defined as follows: Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl.
• •8. Adequate renal and hepatic function within 4 weeks prior to registration, defined as follows: Serum creatinine \< 2.0 mg/dl; Total bilirubin \< 2 x the institutional ULN; AST or ALT \< 3 x the institutional ULN.
• •9. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential
• •10. Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment.
• •11. Patients must be deemed able to comply with the treatment plan and follow-up schedule.
• •12. Patients must provide study specific informed consent prior to study entry