Angiofibroma of Head and Neck, Chondrosarcoma of Head and Neck, Chordoma of Head and Neck, Head and Neck Sarcoma, Nasopharyngeal Carcinoma, Paraganglioma of Head and Neck, Salivary Gland Cancer, Squamous Cell Carcinoma of the Head and Neck
Conditions
Keywords
stereotactic radiosurgery, head and neck tumors, squamous cell carcinoma of head and neck
Brief 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.
Detailed description
This single site, non-randomized, prospective, phase IV study includes 3 patient groups to be treated with SBRT: * Benign tumors, such as paraganglioma, chordoma, chondrosarcoma, as the sole treatment or to gross residual disease after maximal safe resection * Malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, after initial external beam radiation (Residual Disease Group) * Unresectable malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, adenocarcinomas, and sarcomas which are recurrent after prior radiation (Primary RT Group) Data collected will include baseline patient demographics, pathology data, radiation therapy procedure, tumor recurrence data, and toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
Interventions
RADIATIONstereotactic 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)
RADIATIONStereotactic 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)
Sponsors
Mercy Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Control Rate | 5 years | Complete or partial tumor response or stable disease |
| Local Recurrence | 5 years | Instances of progressive disease |
| Complication Rate | 5 years | Number of participants with any adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 5 years | Number of participants who are alive 5 years following treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 1 |
| 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) | 18 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 6 |
| Overall Study | Physician Decision | 0 | 3 |
Baseline characteristics
| Characteristic | Benign Tumors | Unrescectable Malignant Tumors | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 14 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 1 Participants | 15 Participants | 16 Participants |
| Region of Enrollment United States | 1 Participants | 18 Participants | 19 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 16 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 8 / 10 |
| other Total, other adverse events | 1 / 1 | 5 / 8 |
| serious Total, serious adverse events | 0 / 1 | 0 / 8 |
Outcome results
Primary
Complication Rate
Number of participants with any adverse event
Time frame: 5 years
Population: 9 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Benign Tumors | Complication Rate | 1 Participants |
| Malignant Tumors | Complication Rate | 4 Participants |
Primary
Local Control Rate
Complete or partial tumor response or stable disease
Time frame: 5 years
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Benign Tumors | Local Control Rate | 1 Participants |
| Malignant Tumors | Local Control Rate | 5 Participants |
Primary
Local Recurrence
Instances of progressive disease
Time frame: 5 years
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Benign Tumors | Local Recurrence | 0 Participants |
| Malignant Tumors | Local Recurrence | 3 Participants |
Secondary
Overall Survival
Number of participants who are alive 5 years following treatment.
Time frame: 5 years
Population: 9 patients did not have overall survival data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Benign Tumors | Overall Survival | 0 Participants |
| Malignant Tumors | Overall Survival | 2 Participants |