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Stereotactic Body Radiotherapy for Head and Neck Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01344356
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : April 10, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Frazier, MD, Mercy Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Radiation: stereotactic body radiotherapy Radiation: Stereotactic body radiotherapy Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors
Study Start Date : July 2008
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)
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)


Outcome Measures
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Primary Outcome Measures :
  1. Local Control Rate [ Time Frame: 5 years ]
    Complete or partial tumor response or stable disease

  2. Local Recurrence [ Time Frame: 5 years ]
    Instances of progressive disease

  3. Complication Rate [ Time Frame: 5 years ]
    Number of participants with any adverse event


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years ]
    Number of participants who are alive 5 years following treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344356


Locations
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United States, Missouri
St. John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Sponsors and Collaborators
Mercy Research
  Study Documents (Full-Text)

Documents provided by Robert Frazier, MD, Mercy Research:
Study Protocol  [PDF] February 4, 2013
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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Responsible Party: Robert Frazier, MD, Physician, Mercy Research
ClinicalTrials.gov Identifier: NCT01344356    
Other Study ID Numbers: 08-046
First Posted: April 29, 2011    Key Record Dates
Results First Posted: April 10, 2020
Last Update Posted: April 10, 2020
Last Verified: March 2020
Keywords provided by Robert Frazier, MD, Mercy Research:
stereotactic radiosurgery
head and neck tumors
squamous cell carcinoma of head and neck
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Nasopharyngeal Carcinoma
Squamous Cell Carcinoma of Head and Neck
Salivary Gland Neoplasms
Chondrosarcoma
Paraganglioma
Chordoma
Head and Neck Neoplasms
Angiofibroma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Sarcoma
 Neoplasms, Connective and Soft Tissue
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Mouth Neoplasms
Mouth Diseases
Salivary Gland Diseases
Neoplasms, Connective Tissue
Neuroendocrine Tumors
Neuroectodermal Tumors