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

18 Years
Open (Enrolling)
Squamous Cell Carcinoma of the Oropharynx, HPV

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Trial Information

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

The investigators have shown in past experience a high success in getting rid of
oropharyngeal cancer (tonsil or base of tongue cancer) using chemotherapy and radiation
therapy in patients who have not smoked, or only smoked a minimal amount of cigarettes or
equivalent. In these patients, the cancer is thought to be caused by a virus (Human
Papilloma Virus, or HPV). HPV is a virus that infects the epidermis (outermost layer of
skin) and mucous membranes of humans. In general, patients with HPV-related cancer such as
yours have a better prognosis compared with patients whose tumors are smoking-related.
Taking into account the good prognosis, it is possible that reducing the intensity of
therapy will not affect the high rate of tumor control, while reducing the side-effects of
therapy. In this study, the investigators plan to reduce the intensity of treatment by
replacing the currently used chemotherapy drugs with an FDA approved drug, cetuximab, which
is a monoclonal antibody to a growth factor which helps cancer cells grow. By opposing the
effect of the growth factor, cetuximab may help radiotherapy kill cancer cells without a lot
of effect on the normal tissue. It differs from chemotherapy in its more selective activity
against tumors compared to normal tissue Cetuximab has the chance to preserve the high rate
of success in killing the tumor but may reduce the side effects and complications of therapy
in comparison to chemotherapy drugs.

The investigators would also like to know if taking cetuximab has any effect on certain
cancer-related molecules in the cancer and the normal cells inside the cheek. They would
like to test this by taking a small biopsy of the tumor, as well as a swab of the inside of
the cheek, before and shortly after the start of therapy.

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 analysis is required. The
tumor must be HPV(+)/p16(+)

Smoking history <10 pack-year or equivalent (including cigarettes, cigars, pipes,
chewing tobacco, and/or marijuana) Smoking status definitions (National Health Interview
Survey and Behavioral Risk Factor Surveillance System (Nelson DE etal al, Am J Pub Health

- 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

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

- Patients residing in prison

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of Recurrence

Outcome Description:

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.

Outcome Time Frame:

Timepoints throughout 3 years

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 2021

Related Keywords:

  • Squamous Cell Carcinoma of the Oropharynx
  • HPV
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Oropharyngeal Neoplasms



University of Michigan Health System Ann Arbor, Michigan