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slow accrual
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The purpose of this research study is to test the safety of a chemotherapy drug called docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on recurrent head and neck cancer that is not surgically removable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel + Stereotactic Radiation | Experimental | Docetaxel 15mg/m2 IV weekly for 3 weeks. SBRT 25-40 Gy in 5 fractions given twice weekly with each treatment separated by > 48 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel 15mg/m2 IV, given days 1, 8, and 15 during SBRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of acute dose limiting toxicities | Acute dose limiting toxicity is defined as grade 4 or 5 toxicity measured by the Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0, including carotid arterial rupture | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional control | Time from enrollment until local failure or death (whichever comes first) | 2 years |
| Disease-free survival | Time from enrollment until disease progression anywhere in the body or death (whichever comes first) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brad Huth, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati Cancer Institute | Cincinnati | Ohio | 45267-0502 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D016634 | Radiosurgery |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Stereotactic Radiation | Radiation | SBRT will be given over 5 fractions separated by > 48 hours. Dose will be determined based upon dose escalation schedule and will range from 25-40 Gy. |
|
|
| 2 years |
| overall survival | Time from enrollment to death from any cause | 2 years |
| Number of late effect dose limiting toxicities | Occuring > 3 months after treatment completion, including grade 4 and 5 toxicities measured by CTCAE v 4.0 involving skin, mucosa, larynx, pharynx, spinal cord, cranial nerves, and incidence of caroid blowout. | 2 years |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |