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Reduced-intensity Therapy for Advanced Oropharyngeal Cancer in Non-smoking Human Papilloma Virus (HPV)-16 Positive Patients

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Conditions:		Oropharyngeal Cancer
Purpose:		The study aim is to assess whether reducing treatment intensity by replacing concurrent chemotherapy with cetuximab, will indeed achieve improved long-term toxicity. This aim will be tested in a prospective study in which acute and long-term sequelae will be graded by observers using Common Terminology Criteria for Adverse Events (CTCAE) v3 scales), and by patients, Dysphagia will also be assessed objectively by videofluoroscopy.
Study Summary:		These measures will be compared to the investigators historical control group (consisting of non-smoking patients with advanced oropharyngeal cancer who received standard-intensity chemo-radiation therapy and were evaluated by the same tools on UMCC protocol 2-21, IRB # 2002-513). Strict stopping rules will be enacted to ensure that reducing treatment intensity does not increase tumor failures compared with the investigators previous results using standard therapy.
Criteria:		Inclusion Criteria: - pathologically-confirmed, previously untreated, stage IIIIV(excluding N3) squamous cell carcinoma of the oropharynx, without evidence of distant metastasis - Pretreatment tumor biopsy with sufficient tumor for HPV analysis is required. The tumor must be HPV(+)/p16(+) - Never smokers (including cigarettes, cigars, pipes, chewing tobacco, and/or marijuana) - Karnofsky Performance Status (KPS) > 80 - pre-treatment endoscopic tumor staging and PET-CT scanning - appropriate lab levels and creatinine clearance Exclusion Criteria: - Prior head and neck malignancy or history of other prior non-head and neck malignancy (excluding skin cancer and early stage treated prostate cancer) within the past 3 years - Prior head and neck radiation or chemotherapy - Any medical or psychiatric illness, which in the opinion of the principal investigator,would compromise the patient's ability to tolerate this treatment or limit compliance with study requirements - prisoners - Patients with prior anti-epidermal growth-factor receptor antibody therapy (antibody or small molecule)
NCT ID:		NCT01649414
Primary Contact:		Principal Investigator Avraham Eisbruch, MD University of Michigan Cancer Center
Backup Contact:		N/A
Location Contact:		Ann Arbor, Michigan 48109 United States There is no listed contact information for this specific location. Site Status: N/A

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