Nasopharyngeal Carcinoma Clinical Trial
Official title:
Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors
NCT number | NCT01344356 |
Other study ID # | 08-046 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | July 2008 |
Est. completion date | May 2018 |
Verified date | March 2020 |
Source | Mercy Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | May 2018 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | St. John's Mercy Medical Center | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Mercy Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local Control Rate | Complete or partial tumor response or stable disease | 5 years | |
Primary | Local Recurrence | Instances of progressive disease | 5 years | |
Primary | Complication Rate | Number of participants with any adverse event | 5 years | |
Secondary | Overall Survival | Number of participants who are alive 5 years following treatment. | 5 years |
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