Stereotactic Body Radiotherapy for Head and Neck Tumors

Mercy Research

Status and phase: Completed; Phase 4

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

Treatments: Radiation: stereotactic body radiotherapy; Radiation: Stereotactic body radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01344356

08-046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Benign Tumors

Other group

Description:

Benign head and neck tumors will be treated with SBRT

Treatment:

Radiation: stereotactic body radiotherapy

Malignant Tumors

Other group

Description:

Malignant Head and Neck Tumors will be treated with SBRT.

Treatment:

Radiation: Stereotactic body radiotherapy