Stereotactic Body Radiotherapy for Head and Neck Tumors
This trial is active, not recruiting.
|Conditions||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|
|Treatments||stereotactic body radiotherapy|
|Sponsor||St. John's Mercy Research Institute, St. Louis|
|Start date||July 2008|
|End date||July 2017|
|Trial size||50 participants|
|Trial identifier||NCT01344356, 08-046|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
local control rate
time frame: up to 5 years
time frame: 5 years
time frame: 5 years
Male or female participants at least 18 years old.
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
|Official title||Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors|
|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.|
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