Phase III Randomized and Double-blinded Trial of De-escalated Radiation in FMISO PET-selected Good Risk Versus Standard of Care Radiation in Unselected HPV Positive Oropharyngeal Cancer
The researchers are doing this study to find out if a personalized approach to chemoradiation therapy (which may include a lower dose of radiation) is as effective as the standard chemoradiation therapy in people with HPV-positive throat cancer. Other purposes of this study include looking at the following: * Whether a lower dose of radiation in combination with standard chemotherapy causes fewer side effects than the standard dose of radiation therapy in combination with standard chemotherapy * How the study approaches (lower dose of radiation therapy + standard chemotherapy and standard dose of radiation therapy + standard chemotherapy) affect participants' quality of life. The researchers will measure quality of life by having participants fill out questionnaires.
• Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) or squamous cell carcinoma with an unknown primary. Surgical removal of primary site is allowed.
• Patients must test positive for both p16 expression (70% nuclear and cytoplasm expression; Ventana Medical Systems) and mRNA HPV in situ hybridization (RNAscope® 2.5 HD Reagent kit (Advanced Cell Diagnostics, Inc, Hayward, CA). Any CLIA certified testing method can be used.
• Clinical stage Tx-2, N1-2c (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET/CT.
• ECOG Performance Status of 0-1 or KPS \>/=70
• Age ≥ 18
• Adequate hematologic function within 30 days prior to registration, defined as follows:
‣ White Blood Count (WBC) ≥ 2 K/mcL
⁃ Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
⁃ Platelets ≥ 100,000 cells/mm\^3
⁃ Hemoglobin ≥ 10.0 g/dl
• Adequate renal function within 30 days prior to registration, defined as follows:
• o Serum creatinine \< 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dl) x (72)\] CCr female = 0.85 x (CrCl male)
• Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
• The patient must provide study-specific informed consent prior to study entry
• Optional section of the protocol: Patients must be able to undergo MRI scans, i.e. not claustrophobic