Radiation Therapy and Docetaxel in Treating Patients with HPV-Related Oropharyngeal Cancer

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Study phase:

    II What is this?

    During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

  • Site IRB:

    • Scottsdale/Phoenix, Arizona: 12-005272
    • Rochester, Minnesota: 12-005272
  • NCT ID:

  • Sponsor Protocol Number:


About this study

This phase II trial studies how well radiation therapy and docetaxel work in treating patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with docetaxel my kill more tumor cells.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Histological confirmation of HPV+ squamous cell carcinoma of the oropharynx; HPV positivity will be defined as positive staining for p16 on immunohistochemistry (IHC)
  • Gross total surgical resection with curative intent of the primary tumor and at least unilateral neck dissection within 7 weeks of registration
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Smoking history < 10 pack years or equivalent 10 year history of tobacco product use
  • Absence of distant metastases on standard diagnostic work-up ≤ 8 weeks prior to registration; (chest computed tomography [CT], chest x-ray [CXR], positron emission tomography [PET]/CT, etc.)
  • Must have one of the following risk factors:
    • Lymph node > 3 cm
    • 2 or more positive lymph nodes
    • Perineural invasion
    • Lymphovascular space invasion
    • T3 or microscopic T4a primary disease
    • Lymph node extracapsular extension
  • Absolute neutrophil count (ANC) ≥ 1500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Direct bilirubin within upper limit of normal (ULN)
  • Creatinine ≤ ULN x 1.5
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Provide informed written consent
  • Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Exclusion Criteria:

  • Any significant tobacco history within the past five years
  • Any of the following:
    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Other active malignancy ≤ 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
  • History of myocardial infarction ≤ 180 days prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • Prior history of radiation therapy to the affected site
  • History of connective tissue disorders such as rheumatoid arthritis, lupus, or Sjogren's disease
  • Presence of any of the following risk factors after surgery:
    • Any positive surgical margin
    • Adenopathy below the clavicles
  • Prior systemic chemotherapy for the study cancer; NOTE: prior chemotherapy for a different cancer is allowable
  • History of allergic reaction to docetaxel
  • Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
    • Use of strong or moderate inhibitors is prohibited ≤ 7 days prior to registration
  • Receiving any medications or substances that are inducers of CYP3A4
    • Use of inducers is prohibited ≤ 12 days prior to registration

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Daniel Ma, M.D.

Open for enrollment

Cancer Center Clinical Trials Referral Office


Rochester, Minn.

Mayo Clinic principal investigator

Daniel Ma, M.D.

Open for enrollment

Cancer Center Clinical Trials Referral Office