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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02279 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CASE8314 | |||
| CASE 8314 | Other Identifier | Case Comprehensive Cancer Center | |
| P30CA043703 | U.S. NIH Grant/Contract | View source |
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Slow Accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase I trial studies the side effects and best dose of stereotactic body radiation therapy (SBRT) in treating participants with head and neck cancer that has spread from where it started to nearby tissue or lymph nodes and is at high risk for continuing to spread because the participant cannot undergo standard chemotherapy. Stereotactic body radiation therapy is a specialized radiation therapy that delivers radiation directly to the tumor in smaller doses over several days, which may kill more tumor cells and cause less damage to normal tissue.
PRIMARY OBJECTIVES:
I. To explore the maximum tolerated dose of head and neck stereotactic body radiation therapy (SBRT) in a high risk participant population ineligible for standard chemoradiotherapy.
SECONDARY OBJECTIVES:
I. Assess profiles of SBRT toxicity and examine participant (including co-morbidities), tumor and treatment related factors that are associated with SBRT related toxicity.
II. Identify any dose volume parameters that are associated with SBRT related toxicity.
III. Explore potential dose response relationships between higher SBRT dosing and radiographic response.
IV. Assess impact of SBRT on participants' quality of life.
OUTLINE: This is a dose-escalation study.
Participants undergo SBRT in 5 fractions at least 40 hours apart over 10-18 days.
After completion of study treatment, participants are followed up at 0.5, 3, 6, 9, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (SBRT) | Experimental | Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy | Radiation | Undergo SBRT |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Head and Neck SBRT | Maximum tolerated dose of SBRT in this patient population determined by the dose escalation design with doses '40Gy' and '45Gy all in 5 fractions'. | 3 months |
| Incidence of Dose Limiting Toxicities (DLTs) | Number of patients with dose limiting toxicity events graded according to CTCAE Version 4.0 | 3 months from start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Kaplan-Meier estimates will be used to plot overall survival - the number of patients alive at 12 months followup | Up to 12 months |
| Local Progression Free Survival | Kaplan-Meier estimates will be used to plot local progression free survival. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shlomo Koyfman | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (SBRT) | Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2016 |
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| Positron Emission Tomography | Device | Undergo PET/CT |
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| Computed Tomography | Device | Undergo PET/CT |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Up to 12 months |
| Response Measured According to Standard Response Evaluation Criteria in Solid Tumors | Trend tests will be used to investigate the relationship between SBRT dose and response. | Up to 12 months |
| Incidence of SBRT Related Morbidity | Number of patients who experiences SBRT-related morbidity according to NCI CTCAE v 4.0 | Up to 12 months |
| Quality of Life Assessed by Functional Assessment of Cancer Therapy-Head and Neck Questionnaire | Repeated analysis of variance measures will be used to analyze the quality of life data. | Up to 12 months |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (SBRT) | Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Maximum Tolerated Dose (MTD) of Head and Neck SBRT | Maximum tolerated dose of SBRT in this patient population determined by the dose escalation design with doses '40Gy' and '45Gy all in 5 fractions'. | Patients who received treatment. MTD was not able to be determined because only three patients enrolled and no DLTs were observed. A recommended MTD could only be made if enough patients had accrued to assess toxicities in the different dosage levels. | Posted | 3 months |
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| Primary | Incidence of Dose Limiting Toxicities (DLTs) | Number of patients with dose limiting toxicity events graded according to CTCAE Version 4.0 | Participants who enrolled in study and were treated. | Posted | Number | Participants | 3 months from start of treatment |
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| Secondary | Overall Survival | Kaplan-Meier estimates will be used to plot overall survival - the number of patients alive at 12 months followup | Patients who went on study | Posted | Count of Participants | Participants | Up to 12 months |
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| Secondary | Local Progression Free Survival | Kaplan-Meier estimates will be used to plot local progression free survival. | No patients were alive at 12 months, so no analysis was done. | Posted | Up to 12 months |
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| Secondary | Response Measured According to Standard Response Evaluation Criteria in Solid Tumors | Trend tests will be used to investigate the relationship between SBRT dose and response. | There was insufficient patient accrual to perform additional statistical analysis. | Posted | Up to 12 months |
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| Secondary | Incidence of SBRT Related Morbidity | Number of patients who experiences SBRT-related morbidity according to NCI CTCAE v 4.0 | Patients who were eligible for evaluation for SBRT-related morbidity incidence | Posted | Count of Participants | Participants | Up to 12 months |
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| Secondary | Quality of Life Assessed by Functional Assessment of Cancer Therapy-Head and Neck Questionnaire | Repeated analysis of variance measures will be used to analyze the quality of life data. | No patient was able to complete 3 month follow up to provide this QOL information | Posted | Up to 12 months |
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Adverse events were collected from start of treatment to end of study (over a period of approximately 6 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (SBRT) | Patients undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Stereotactic Body Radiation Therapy: Undergo SBRT Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT Quality-of-Life Assessment: Ancillary studies | 3 | 3 | 0 | 3 | 1 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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Due to slow accrual the study was terminated early.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shlomo Koyfman, MD | Cleveland Clinic, Case Comprehensive Cancer Center | 216-444-7552 | koyfmas@ccf.org |
| Sep 26, 2018 |
| Prot_SAP_000.pdf |
| 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 |
| D049268 | Positron-Emission Tomography |
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
| D011856 | Radiographic Image Enhancement |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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