Stereotactic Body Radiotherapy for Head and Neck Tumors

NCT01344356 | Completed Phase 4 Results

• 1 other identifier: 08-046
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

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

Keywords

stereotactic radiosurgery; head and neck tumors; squamous cell carcinoma of head and neck

Outcome Measures

Primary Outcomes (3)

• Local Control Rate

  Complete or partial tumor response or stable disease

  5 years

• Local Recurrence

  Instances of progressive disease

  5 years

• Complication Rate

  Number of participants with any adverse event

  5 years

Secondary Outcomes (1)

• Overall Survival

  5 years

Study Arms (2)

Benign Tumors

OTHER

Benign head and neck tumors will be treated with SBRT

Radiation: stereotactic body radiotherapy

Malignant Tumors

OTHER

Malignant Head and Neck Tumors will be treated with SBRT.

Radiation: Stereotactic body radiotherapy

Interventions

Stereotactic body radiotherapy 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)

Benign Tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mercy Research: lead

Study Sites (1)

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Nasopharyngeal Carcinoma; Salivary Gland Neoplasms; Head and Neck Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Neoplasms; Mouth Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Mercy Research Manager - Regulatory Operations
• Organization: Mercy Research

michelle.bryant@mercy.net

314-251-8827

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: April 29, 2011
• Study Start: July 1, 2008
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 10, 2020
• Results First Posted: April 10, 2020

Record last verified: 2020-03

Locations

US (1)