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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-10828 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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To learn if it is effective to use advanced radiation treatment techniques (stereotactic radiation or "SBRT") to safely deliver a strong dose of radiation to your tumor in a shorter period of time than would typically be feasible with traditional methods.
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Palliation | Experimental | Participant will be randomized to standard radiation |
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| Stereotactic body radiotherapy (SBRT) | Experimental | Participants will be randomized to receive (SBRT) Stereotactic body radiotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic body radiotherapy | Radiation | Participants will receive radiation as per the schedule discussed with the study doctor. |
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| Measure | Description | Time Frame |
|---|---|---|
| M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires | M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) score range from 0/10 (0-symptom has not been present)0 to 10 (10-the symptom was as bad as you can imagine it could be) | through study completion; an average of 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
5.0 PRE-TREATMENT EVALUATION
History and physical examination including laryngopharyngoscopy by a radiation oncologist and/or head and neck surgeon within 8 weeks prior to randomization.
o Clinical examination will include a detailed description of disease target including measurement where feasible to facilitate response assessment
Documentation of smoking history
Staging imaging within 12 weeks prior to randomization:
Histological confirmation of squamous cell carcinoma
Pregnancy test for women of child-bearing age, within 2 weeks prior to randomization
Assessment of all baseline symptoms, using CTCAE version 5.0 within 2 weeks prior to randomization.
Assessment of baseline pain score (NRS) and analgesic use (non-opioid and opioid)
Completion of QOL scoring within 2 weeks of randomization
Informed consents must be obtained prior to any study specific activities
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jay Reddy, MD,PHD | Contact | (832) 750-2924 | jreddy@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Jay Reddy, MD,PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Traditional Palliation | Radiation | Participants will receive radiation as per the schedule discussed with the study doctor. |
|
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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