Stereotactic Body Radiotherapy for Head and Neck Tumors
|ClinicalTrials.gov Identifier: NCT01344356|
Recruitment Status : Active, not recruiting
First Posted : April 29, 2011
Last Update Posted : April 20, 2016
|Condition or disease||Intervention/treatment||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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2017|
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 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)
- 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.
- overall survival [ Time Frame: 5 years ]patients will be followed for up to 5 years for survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344356
|United States, Missouri|
|St. John's Mercy Medical Center|
|St. Louis, Missouri, United States, 63141|