Reduced-intensity Therapy for Oropharyngeal Cancer in Non-smoking HPV-16 Positive Patients

• Status: Completed
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Taking into account the excellent prognosis of patients with HPV-positive oropharyngeal cancer with < 10 pack-year smoking, the investigators hypothesize that reducing the intensity of therapy for these patients will reduce treatment sequelae, notably long-term dysphagia, without affecting their cure rates. The main Aim is to assess whether reducing treatment intensity, by replacing concurrent chemotherapy with cetuximab, will indeed achieve improved long-term toxicity.

The primary objectives include the following: to confirm that reducing treatment intensity in patients with HPV-related oropharyngeal cancer and < 10 pack-year smoking history by replacing concurrent chemotherapy with concurrent cetuximab, does not significantly increase the proportion of patients whose tumors recur, compared to our previous experience in similar patients receiving chemo-RT and to compare the toxicity in patients receiving cetuximab-RT to similar patients treated with 7 weeks of chemotherapy concurrent with RT ("standard therapy") in UMCC 2-21.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Patients must have pathologically-confirmed, previously untreated,stage III-IV(excluding N3 or T4) squamous cell carcinoma of the oropharynx, without evidence of distant metastasis

• Pretreatment tumor biopsy with sufficient tumor for HPV or p16 analysis is required. The tumor must be HPV(+) or p16(+)

Smoking history <10 pack-year or equivalent (including cigarettes, cigars, pipes, chewing tobacco, and/or marijuana). One cannabis joint is equivalent to 5 cigarettes. (Aldington etal, Thorax 2007; 62:1058-1063). Smoking status definitions (National Health Interview Survey and Behavioral Risk Factor Surveillance System (Nelson DE etal al, Am J Pub Health 2003;93:1335):

• Smokers: smoking now every day or some days in past month

• Quitters: at least 100 cigarettes/lifetime and not smoking in the past 1-12 months

• Former smoker: at least 100 cigarettes/lifetime and not smoking >12 months

• Never smokers: <100 cigarettes (or equivalent)/lifetime

• KPS > 80 (see Appendix A)

• Patients must undergo pre-treatment endoscopic tumor staging and PET-CT scanning

• Laboratory criteria:

• WBC > 3500/ul

• granulocyte > 1500/ul

• Platelet count > 100,000/ul

• Total Bilirubin < 1.5 X ULN

• AST and ALT < 2.5 X ULN

• Creatinine clearance >30 cc/min

• Patients must sign study specific informed consent

• Patients must have, in the opinion of a treating physician, tumor that is accessible to biopsy in the clinic.

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

• Patients residing in prison

• Patients with prior anti-epidermal growth-factor receptor antibody therapy (antibody or small molecule)