Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer

Summary: This phase I trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with head and neck cancer that has spread from where it started to nearby tissue or lymph nodes and is at high risk for continuing to spread because the patient cannot undergo standard chemotherapy. Stereotactic body radiation therapy is a specialized radiation therapy that delivers radiation directly to the tumor in smaller doses over several days, which may kill more tumor cells and cause less damage to normal tissue.

Detailed description: PRIMARY OBJECTIVES:
  I. To explore the maximum tolerated dose of head and neck stereotactic body radiation therapy (SBRT) in a high risk patient population ineligible for standard chemoradiotherapy.
  SECONDARY OBJECTIVES:
  I. Assess profiles of SBRT toxicity and examine patient (including co-morbidities), tumor and treatment related factors that are associated with SBRT related toxicity.
  II. Identify any dose volume parameters that are associated with SBRT related toxicity.
  III. Explore potential dose response relationships between higher SBRT dosing and radiographic response.
  IV. Assess impact of SBRT on patients' quality of life.
  OUTLINE: This is a dose-escalation study.
  Patients undergo SBRT in 5 fractions at least 40 hours apart over 10-18 days.
  After completion of study treatment, patients are followed up at 0.5, 3, 6, 9, and 12 months.

Eligibility: Inclusion Criteria:
  -  The patient must have squamous cell carcinoma proven by histologic diagnosis; for cancers of the oropharynx, p16 staining by immunohistochemistry must be negative; for cancers of the larynx, hypopharynx, oral cavity, nasopharynx, paranasal sinuses, p16 staining is not required
  -  The patient must have clinical stage T1-4, N0-3, M0-1, stage II-IVC carcinoma as per the 7th edition of the American Joint Committee on Cancer (AJCC) staging manual; patients with T1N0M0 will be ineligible; patients with metastatic disease with a limited metastatic burden are eligible if obtaining local control is determined by their treating oncologist to be an important therapeutic goal
  -  The patient must have imaging documenting a primary tumor, or involved lymph node, ≥ 2.5 cm in greatest dimension
  -  PET/CT is required for all patients, unless contraindicated; this may be acquired prior to study entry or after enrollment prior to SBRT planning
  -  The patient must have a history and physical documented within four weeks of registration and be deemed by a medical oncologist to be ineligible for standard continuous course chemoradiotherapy with cisplatin
  -  Karnofsky performance status (PS) ≥ 40
  -  Female patients cannot be of childbearing age, or if they are, must have a negative pregnancy test prior to enrollment and be willing to use contraceptives during treatment and continue for 6 additional months
  -  Patients must have the ability to understand and the willingness to sign a written informed consent document
  Exclusion Criteria:
  -  Patients with T1N0M0 stage I disease
  -  Patients who are receiving any other investigational agents
  -  Patients with non-squamous cell histology
  -  Patients with life expectancy < 6 months
  -  Patients who cannot lie flat for 20 minutes
  -  Patients with prior history of head and neck radiotherapy (> 40 Gy) with significant areas of anticipated overlap

Relevance to patient case: not relevant