Stereotactic Body Radiotherapy for Head and Neck Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bethany Sleckman, St. John's Mercy Research Institute, St. Louis
ClinicalTrials.gov Identifier:
NCT01344356
First received: April 27, 2011
Last updated: January 30, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 St. John's Mercy Research Institute, St. Louis:

Primary Outcome Measures:
  • local control rate [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Toxicities will be recorded using CTC grading criteria at specified timepoints.


Secondary Outcome Measures:
  • overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    patients will be followed for up to 5 years for survival


Estimated Enrollment: 50
Study Start Date: July 2008
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 27, 2011
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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:
Angiofibroma
Carcinoma
Carcinoma, Squamous Cell
Chondrosarcoma
Head and Neck Neoplasms
Nasopharyngeal Neoplasms
Paraganglioma
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Squamous Cell
Neoplasms, Vascular Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Sarcoma
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 30, 2014