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Stereotactic Body Radiotherapy for Head and Neck Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01344356
First Posted: April 29, 2011
Last Update Posted: April 20, 2016
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.
Information provided by (Responsible Party):
Bethany Sleckman, St. John's Mercy Research Institute, St. Louis
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bethany Sleckman, St. John's Mercy Research Institute, St. Louis:

Primary Outcome Measures:
  • local control rate [ Time Frame: up to 5 years ]
    Routine follow up will consist of CT scan of the soft tissues of the neck with IV contrast (MRI may be used). Local recurrence is defined as tumor recurrence within the planning target volume. If necessary, a PET/CT scan may be used to aid in diagnoses local tumor recurrence. A local recurrence is defined as cancer recurrence within the planning target volume.Distant metastases will not be considered a treatment failure unless accompanied by local recurrence.

  • complication rates [ Time Frame: 5 years ]
    Toxicities will be recorded using CTC grading criteria at specified timepoints.


Secondary Outcome Measures:
  • overall survival [ Time Frame: 5 years ]
    patients will be followed for up to 5 years for survival


Estimated Enrollment: 50
Study Start Date: July 2008
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, Missouri
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
Sponsors and Collaborators
St. John's Mercy Research Institute, St. Louis
  More Information

Responsible Party: Bethany Sleckman, Principal Investigator, St. John's Mercy Research Institute, St. Louis
ClinicalTrials.gov Identifier: NCT01344356     History of Changes
Other Study ID Numbers: 08-046
First Submitted: April 27, 2011
First Posted: April 29, 2011
Last Update Posted: April 20, 2016
Last Verified: April 2016

Keywords provided by Bethany Sleckman, St. John's Mercy Research Institute, St. Louis:
stereotactic radiosurgery
head and neck tumors
squamous cell carcinoma of head and neck

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Nasopharyngeal Neoplasms
Head and Neck Neoplasms
Salivary Gland Neoplasms
Chondrosarcoma
Paraganglioma
Carotid Body Tumor
Chordoma
Angiofibroma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
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
Neoplasms, Connective and Soft Tissue
Sarcoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal