Clinical Trial: Stereotactic Body Radiotherapy for Head and Neck Tumors

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: St. John's Mercy Research Institute, St. Louis

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome: overall survival [ Time Frame: 5 years ]

patients will be followed for up to 5 years for survival


Original Secondary Outcome: Same as current

Information By: St. John's Mercy Research Institute, St. Louis

Dates:
Date Received: April 27, 2011
Date Started: July 2008
Date Completion: July 2017
Last Updated: April 18, 2016
Last Verified: April 2016