Stereotactic Body Radiotherapy for Head and Neck Tumors

March 28, 2020 updated by: Robert Frazier, MD, Mercy Research

Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • St. John's Mercy Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Benign Tumors
Benign head and neck tumors will be treated with SBRT
Radiation: 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)
OTHER: Malignant Tumors
Malignant Head and Neck Tumors will be treated with SBRT.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Control Rate
Time Frame: 5 years
Complete or partial tumor response or stable disease
5 years
Local Recurrence
Time Frame: 5 years
Instances of progressive disease
5 years
Complication Rate
Time Frame: 5 years
Number of participants with any adverse event
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 5 years
Number of participants who are alive 5 years following treatment.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mercy Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (ESTIMATE)

April 29, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 10, 2020

Last Update Submitted That Met QC Criteria

March 28, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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