Trial record 13 of 26 for:
Open Studies | "Salivary Gland Neoplasms"
Stereotactic Body Radiotherapy for Head and Neck Tumors
This study is currently recruiting participants.
Verified December 2012 by St. John's Mercy Research Institute, St. Louis
Sponsor:
St. John's Mercy Research Institute, St. Louis
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: December 12, 2012
Last verified: December 2012
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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:
Genetics Home Reference related topics:
chordoma
hereditary paraganglioma-pheochromocytoma
nonsyndromic paraganglioma
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344356
Locations
| United States, Missouri | |
| St. John's Mercy Medical Center | Recruiting |
| St. Louis, Missouri, United States, 63141 | |
| Contact: Robert Frazier, MD 314-251-6844 robert.frazier@mercy.net | |
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: | December 12, 2012 |
| 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:
|
Salivary Gland Neoplasms Carcinoma Carcinoma, Squamous Cell Chondrosarcoma Chordoma Head and Neck Neoplasms Paraganglioma Angiofibroma Sarcoma Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms, Connective Tissue |
Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms by Site Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Mouth Neoplasms Mouth Diseases Stomatognathic Diseases Salivary Gland Diseases Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Nasopharyngeal Diseases Pharyngeal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013