Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Sponsor
- Mercy Research
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Local Control Rate
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study will evaluate the local control rates as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck tumors.
Detailed Description
This single site, non-randomized, prospective, phase IV study includes 3 patient groups to be treated with SBRT: * Benign tumors, such as paraganglioma, chordoma, chondrosarcoma, as the sole treatment or to gross residual disease after maximal safe resection * Malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, after initial external beam radiation (Residual Disease Group) * Unresectable malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, adenocarcinomas, and sarcomas which are recurrent after prior radiation (Primary RT Group) Data collected will include baseline patient demographics, pathology data, radiation therapy procedure, tumor recurrence data, and toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
Investigators
Robert Frazier, MD
Physician
Mercy Research
Eligibility Criteria
Inclusion Criteria
- •Patient age \> 18 years
- •Zubrod performance status of 0-3
- •Benign head and neck tumors such as paragangliomas, chordoma, chondrosarcoma
- •Malignant head and neck cancers such as invasive squamous cell carcinoma, adenocarcinoma, nasopharyngeal carcinoma, salivary gland cancers, and sarcoma
- •Signed study-specific consent form
Exclusion Criteria
- •Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
- •Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
Outcomes
Primary Outcomes
Local Control Rate
Time Frame: 5 years
Complete or partial tumor response or stable disease
Local Recurrence
Time Frame: 5 years
Instances of progressive disease
Complication Rate
Time Frame: 5 years
Number of participants with any adverse event
Secondary Outcomes
- Overall Survival(5 years)