Phase 4
N=19
Stereotactic Body Radiotherapy for Head and Neck Tumors
Squamous Cell Carcinoma of the Head and Neck · Nasopharyngeal Carcinoma · Salivary Gland Cancer · Head and Neck Sarcoma · Paraganglioma of Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT01344356 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Local Control Rate — 1; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- stereotactic body radiotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mercy Research
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Control Rate |
1; 5 | — |
| PRIMARY Local Recurrence |
0; 3 | — |
| PRIMARY Complication Rate |
1; 4 | — |
| SECONDARY Overall Survival |
0; 2 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01344356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.