Recurrent Laryngeal Squamous Cell Carcinoma Clinical Trial
Official title:
Phase I Dose Escalation Study of Stereotactic Body Radiotherapy for Carcinoma of the Head and Neck in High Risk Patients Who Are Ineligible/Refuse Standard of Care Therapy
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.
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|---|---|---|---|
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