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

Phase 2
18 Years
Open (Enrolling)
Oropharyngeal Cancer

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Trial Information

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

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.

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

- 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

- 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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with Tumor Reoccurrence

Outcome Description:

To confirm that reducing treatment intensity in non-smoking patients with HPV related oropharyngeal cancer 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-radiation therapy (RT).

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Avraham Eisbruch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center


United States: Institutional Review Board

Study ID:

UMCC 2009-078



Start Date:

June 2010

Completion Date:

January 2016

Related Keywords:

  • Oropharyngeal Cancer
  • oral cancer
  • Papilloma
  • Oropharyngeal Neoplasms



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752