Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT02388932
Brief Summary:
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.
Detailed Description:
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:
NCT02388932
Study Brief:
Protocol Section:
NCT02388932