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Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors


Phase 4
18 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

local control rate

Outcome Description:

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.

Outcome Time Frame:

up to 5 years

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

08-046

NCT ID:

NCT01344356

Start Date:

July 2008

Completion Date:

July 2015

Related Keywords:

  • 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
  • stereotactic radiosurgery
  • head and neck tumors
  • squamous cell carcinoma of head and neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Chondrosarcoma
  • Chordoma
  • Head and Neck Neoplasms
  • Paraganglioma
  • Angiofibroma
  • Salivary Gland Neoplasms
  • Sarcoma
  • Nasopharyngeal Neoplasms

Name

Location
St. John's Mercy Medical Center Saint Louis, Missouri  63141