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Stereotactic Body Radiotherapy for Head and Neck Tumors

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ClinicalTrials.gov Identifier: NCT01344356
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Frazier, MD, Mercy Research

Tracking Information
First Submitted Date  ICMJE April 27, 2011
First Posted Date  ICMJE April 29, 2011
Last Update Posted Date December 31, 2018
Study Start Date  ICMJE July 2008
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01344356 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
overall survival [ Time Frame: 5 years ]
patients will be followed for up to 5 years for survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stereotactic Body Radiotherapy for Head and Neck Tumors
Official Title  ICMJE Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • Benign Tumors
    Benign head and neck tumors will be treated with SBRT
    Intervention: Radiation: stereotactic body radiotherapy
  • Malignant Tumors
    Malignant Head and Neck Tumors will be treated with SBRT.
    Intervention: Radiation: Stereotactic body radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 27, 2018)
19
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2011)
50
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01344356
Other Study ID Numbers  ICMJE 08-046
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Frazier, MD, Mercy Research
Study Sponsor  ICMJE Mercy Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mercy Research
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP