Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Nasopharyngeal Carcinoma

Paraganglioma

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Sarcoma

Chondrosarcoma

Chordoma

Angiofibroma

Salivary Gland Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Neoplasms, Connective and Soft Tissue

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Mouth Neoplasms

Mouth Diseases

Salivary Gland Diseases

Neoplasms, Connective Tissue

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neoplasms, Vascular Tissue

Paragangliomas 1

Soft Tissue Sarcoma

Oral Cancer

Neuroendocrine Tumor

Neuroepithelioma

Benign head and neck tumors will be treated with SBRT

Malignant Head and Neck Tumors will be treated with SBRT.

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)

stereotactic body radiotherapy

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)

Stereotactic body radiotherapy

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.

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.

Stereotactic Body Radiotherapy for Head and Neck Tumors

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

Complete or partial tumor response or stable disease

Number of participants with any adverse event

Number of participants who are alive 5 years following treatment.

Mercy Research

Physician

Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0

Benign head and neck tumors will be treated with SBRT

stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)

Benign Tumors

Malignant Head and Neck Tumors will be treated with SBRT.

Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)

Malignant Tumors

Benign head and neck tumors will be treated with SBRT

stereotactic body radiotherapy: 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)

Malignant Head and Neck Tumors will be treated with SBRT.

Stereotactic body radiotherapy: 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)

Unrescectable Malignant Tumors

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Mercy Research Manager - Regulatory Operations

12 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.

Local Control Rate

12 patients did not have local recurrence rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.

Local Recurrence

Benign head and neck tumors will be treated with Stereotactic body radiotherapy

stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)

Malignant Head and Neck Tumors will be treated with Stereotactic body radiotherapy.

Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)

9 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.

Complication Rate

9 patients did not have overall survival data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.

Overall Survival

Benign head and neck tumors will be treated with stereotactic body radiation therapy

stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)

Malignant Head and Neck Tumors will be treated with stereotactic body radiation therapy.

Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)

Spots Global Cancer Trial Database for head and neck sarcoma