This phase I trial studies the side effects and best dose of stereotactic body radiation therapy (SBRT) in treating participants 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 participant 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.
PRIMARY OBJECTIVES: I. To explore the maximum tolerated dose of head and neck stereotactic body radiation therapy (SBRT) in a high risk participant population ineligible for standard chemoradiotherapy. SECONDARY OBJECTIVES: I. Assess profiles of SBRT toxicity and examine participant (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 participants' quality of life. OUTLINE: This is a dose-escalation study. Participants undergo SBRT in 5 fractions at least 40 hours apart over 10-18 days. After completion of study treatment, participants are followed up at 0.5, 3, 6, 9, and 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Undergo SBRT
Undergo PET/CT
Undergo PET/CT
Ancillary studies
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Maximum Tolerated Dose (MTD) of Head and Neck SBRT
Maximum tolerated dose of SBRT in this patient population determined by the dose escalation design with doses '40Gy' and '45Gy all in 5 fractions'.
Time frame: 3 months
Incidence of Dose Limiting Toxicities (DLTs)
Number of patients with dose limiting toxicity events graded according to CTCAE Version 4.0
Time frame: 3 months from start of treatment
Overall Survival
Kaplan-Meier estimates will be used to plot overall survival - the number of patients alive at 12 months followup
Time frame: Up to 12 months
Local Progression Free Survival
Kaplan-Meier estimates will be used to plot local progression free survival.
Time frame: Up to 12 months
Response Measured According to Standard Response Evaluation Criteria in Solid Tumors
Trend tests will be used to investigate the relationship between SBRT dose and response.
Time frame: Up to 12 months
Incidence of SBRT Related Morbidity
Number of patients who experiences SBRT-related morbidity according to NCI CTCAE v 4.0
Time frame: Up to 12 months
Quality of Life Assessed by Functional Assessment of Cancer Therapy-Head and Neck Questionnaire
Repeated analysis of variance measures will be used to analyze the quality of life data.
Time frame: Up to 12 months
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