Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
local control rate
Routine follow up will consist of CT scan of the soft tissues of the neck with IV contrast (MRI may be used). Local recurrence is defined as tumor recurrence within the planning target volume. If necessary, a PET/CT scan may be used to aid in diagnoses local tumor recurrence. A local recurrence is defined as cancer recurrence within the planning target volume.Distant metastases will not be considered a treatment failure unless accompanied by local recurrence.
up to 5 years
United States: Institutional Review Board
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