Stereotactic Body Radiotherapy for Head and Neck Tumors

Phase 4

Completed

• Conditions: Nasopharyngeal Carcinoma; Chordoma of Head and Neck; Angiofibroma of Head and Neck; Squamous Cell Carcinoma of the Head and Neck; Paraganglioma of Head and Neck; Salivary Gland Cancer; Head and Neck Sarcoma; Chondrosarcoma of Head and Neck
• Interventions: Radiation: Stereotactic body radiotherapy

• Registration Number: NCT01344356
• Lead Sponsor: Mercy Research

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-29
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Results First Submitted: 2020-02-28
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-28
• Last Update Submitted: 2020-03-28
• Results First Posted: 2020-04-10
• Last Update Posted: 2020-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Benign Tumors	Stereotactic body radiotherapy	Benign head and neck tumors will be treated with SBRT
Malignant Tumors	Stereotactic body radiotherapy	Malignant Head and Neck Tumors will be treated with SBRT.

Primary Outcome Measures

Name	Time	Method
Local Control Rate	5 years	Complete or partial tumor response or stable disease
Local Recurrence	5 years	Instances of progressive disease
Complication Rate	5 years	Number of participants with any adverse event

Secondary Outcome Measures

Name	Time	Method
Overall Survival	5 years	Number of participants who are alive 5 years following treatment.

Trial Locations

Locations (1)

St. John's Mercy Medical Center; 🇺🇸 Saint Louis, Missouri, United States