Stereotactic Body Radiotherapy for Head and Neck Tumors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Benign Tumors

Benign head and neck tumors will be treated with SBRT

Group Type OTHER

stereotactic body radiotherapy

Intervention Type RADIATION

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 Tumors

Malignant Head and Neck Tumors will be treated with SBRT.

Group Type OTHER

Stereotactic body radiotherapy

Intervention Type RADIATION

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)

Interventions

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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)

Intervention Type RADIATION

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)

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No