Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This single site, non-randomized, prospective, phase IV study includes 3 patient groups to be treated with SBRT:
Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benign Tumors | Other | Benign head and neck tumors will be treated with SBRT |
|
| Malignant Tumors | Other | Malignant Head and Neck Tumors will be treated with SBRT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic body radiotherapy | Radiation | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Control Rate | Complete or partial tumor response or stable disease | 5 years |
| Local Recurrence | Instances of progressive disease | 5 years |
| Complication Rate | Number of participants with any adverse event | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Number of participants who are alive 5 years following treatment. | 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. John's Mercy Medical Center | St Louis | Missouri | 63141 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Benign Tumors | Benign head and neck tumors will be treated with stereotactic body radiation therapy stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction) |
| FG001 | Unrescectable Malignant Tumors |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2013 | Feb 18, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Stereotactic body radiotherapy | Radiation | 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) |
|
Malignant Head and Neck Tumors will be treated with stereotactic body radiation therapy. Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Benign Tumors | Benign head and neck tumors will be treated with SBRT 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) |
| BG001 | Unrescectable Malignant Tumors | Malignant Head and Neck Tumors will be treated with SBRT. 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) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Local Control Rate | Complete or partial tumor response or stable disease | 12 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected. | Posted | Count of Participants | Participants | 5 years |
|
|
| |||||||||||||||||||||||||||||
| Primary | Local Recurrence | Instances of progressive disease | 12 patients did not have local recurrence rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected. | Posted | Count of Participants | Participants | 5 years |
|
| ||||||||||||||||||||||||||||||
| Primary | Complication Rate | Number of participants with any adverse event | 9 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. | Posted | Count of Participants | Participants | 5 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Number of participants who are alive 5 years following treatment. | 9 patients did not have overall survival data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. | Posted | Count of Participants | Participants | 5 years |
|
|
5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Benign Tumors | Benign head and neck tumors will be treated with SBRT stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction) | 0 | 1 | 0 | 1 | 1 | 1 |
| EG001 | Malignant Tumors | Malignant Head and Neck Tumors will be treated with SBRT. Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction) | 8 | 10 | 0 | 8 | 5 | 8 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hoarseness | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cranial Nerve Neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mercy Research Manager - Regulatory Operations | Mercy Research | 314-251-8827 | michelle.bryant@mercy.net |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D000077274 | Nasopharyngeal Carcinoma |
| D012468 | Salivary Gland Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009062 | Mouth Neoplasms |
| D009059 | Mouth Diseases |
| D012466 | Salivary Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|