Details

Details

Title Phase I Dose Escalation Study of Stereotactic Body Radiotherapy for p16 Negative Squamous Cell Carcinoma of the Head and Neck in High Risk Patients Who are Ineligible/Refuse Standard of Care Therapy

IRB CASE8314

CC 15-006

Hospital Main Campus

Phase Phase 1

Disease Head and Neck

Description

Description

Primary Objective
  • To explore the maximum tolerated dose of head and neck SBRT in a high risk patient population ineligible for standard chemoradiotherapy. Two dose levels will be used: 40Gy, 45Gy all in 5 fractions.
Secondary Objectives:
  • Assess profiles of SBRT toxicity and examine patient (including co-morbidities), tumor and treatment related factors that are associated with SBRT related toxicity
  • Identify any dose volume parameters that are associated with SBRT related toxicity
  • Explore potential dose response relationships between higher SBRT dosing and radiographic response
  • Assess impact of SBRT on patients quality of life
Inclusion Criteria

Inclusion Criteria

  1. The patient must have squamous cell carcinoma, adenocarcinoma or malignant salivary gland cancer (e.g. acinic cell, adenoid cystic, mucoepidermoid, salivary duct carcinoma) proven by histologic diagnosis. Both mucosal and cutaneous cancers are eligible.
  2. The patient must have clinical stage T1-4, N0-3, M0-1, stage II-IVC carcinoma as per the 7th edition of the 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.
  3. The patient must have imaging documenting a primary tumor, or involved lymph node, ≥2.5cm in greatest dimension.
  4. PET/CT is required for all patients, unless contraindicated. This may be acquired prior to study entry or after enrollment prior to SBRT planning.
  5. 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, or refuse treatment with Cisplatin.
  6. Performance status - Karnofsky PS ≥ 40
  7. Age ≥18 years.
  8. Female patients can not 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.
  9. Patients must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria

Exclusion Criteria

  1. Patients with T1N0M0 stage I disease.
  2. Patients who are receiving any other investigational agents.
  3. Patients with non-squamous cell histology.
  4. Patients with life expectancy <6 months.
  5. Patients who cannot lie flat for 20 minutes.
  6. Patients with prior history of head and neck radiotherapy (>40Gy) with significant areas of anticipated overlap