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
Phase phase 4
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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)

Primary Outcomes

local control rate
time frame: up to 5 years
complication rates
time frame: 5 years

Secondary Outcomes

overall survival
time frame: 5 years

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by St. John's Mercy Research Institute, St. Louis.