Trials / Terminated

TerminatedNCT02388932

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

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

Status: Terminated
Phase: N/A
Study type: Interventional
Enrollment: 3 (actual)

Sponsor: Case Comprehensive Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT
DEVICE	Positron Emission Tomography	Undergo PET/CT
DEVICE	Computed Tomography	Undergo PET/CT
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

Start date: 2015-03-03
Primary completion: 2017-02-06
Completion: 2017-02-06
First posted: 2015-03-17
Last updated: 2019-01-24
Results posted: 2018-11-16

Locations

2 sites across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT02388932. Inclusion in this directory is not an endorsement.