Stereotactic Body Radiotherapy for Head and Neck Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors

Conditions
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Squamous Cell Carcinoma of the Head and Neck, Nasopharyngeal Carcinoma, Salivary Gland Cancer, Head and Neck Sarcoma, Paraganglioma of Head and Neck, Chordoma of Head and Neck, Chondrosarcoma of Head and Neck, Angiofibroma of Head and Neck

Intervention / Treatment
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* Radiation: stereotactic body radiotherapy
* Radiation: Stereotactic body radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Benign Tumors<br>Benign head and neck tumors will be treated with SBRT | Radiation: stereotactic body radiotherapy<br>* 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)<br>|
| Other: Malignant Tumors<br>Malignant Head and Neck Tumors will be treated with SBRT. | Radiation: Stereotactic body radiotherapy<br>* 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control Rate | Complete or partial tumor response or stable disease | 5 years | 
| Local Recurrence | Instances of progressive disease | 5 years | 
| Complication Rate | Number of participants with any adverse event | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Number of participants who are alive 5 years following treatment. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stereotactic radiosurgery, head and neck tumors, squamous cell carcinoma of head and neck