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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00285 | Other Identifier | NCI/CTRP | |
| CASE13808 | Other Identifier | Case Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This clinical trial studies stereotactic radiosurgery using CyberKnife works in treating women with advanced or recurrent gynecological malignancies.
PRIMARY OBJECTIVES:
I. The primary goal of this study is to estimate the rate of grade 3 or higher acute toxicities observed during a 6 month period following CyberKnife radiosurgery for gynecologic cancers.
II. To evaluate clinical response to radio-surgery for gynecologic tumors.
III. To assess general and site specific quality of life (using SF-12, FACT-En, FACT-O, FACT-Cx or FACT-V) and to evaluate patient's level of pain.
SECONDARY OBJECTIVES:
I. As a secondary objective, toxicities during the 2 years following CyberKnife radiosurgery will also be described.
OUTLINE:
Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I: CyberKnife Radiosurgery | Experimental | Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic radiosurgery | Radiation | Radiation will be delivered in 3 fractions. The dose level will range between 500 to 800cGy per fraction at the discretion of the treating radiation oncologist |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Toxicity Rate | The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period. | at 6 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival | Median disease free survival | completion of study at 24 months |
| Median Overall Survival | Length of time patients survived at study end. |
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Inclusion
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Robert DeBernardo, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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Between July 24,2009 and September 7, 2011, 50 patients were recruited from University Hospitals in Cleveland Ohio.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I: CyberKnife Radiosurgery | Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| quality-of-life assessment | Procedure | Ancillary studies |
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| 24 months |
| Quality of Life | After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months. |
| Clinical Response Rate | Percentage of patients with a clinical response following RECIST (Response Evaluation Criteria in Solid Tumors) Criteria: Confirmed complete response(CR), Stable disease (SD), partial response (PR), or without progressive disease (PD). | at 6 months from study entry |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I: CyberKnife Radiosurgery | Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery. |
| 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 | Median | Full Range | years |
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| 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 | Acute Toxicity Rate | The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period. | Intent to treat | Posted | Number | percentage of participants | at 6 months after treatment |
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| Secondary | Disease-free Survival | Median disease free survival | Intent to treat | Posted | Median | 95% Confidence Interval | months | completion of study at 24 months |
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| Secondary | Median Overall Survival | Length of time patients survived at study end. | Intent to treat | Posted | Median | 95% Confidence Interval | months | 24 months |
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| Secondary | Quality of Life | Participant surveys were unreliably returned to investigators, making this analysis not meaningful. | Posted | After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months. |
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| Secondary | Clinical Response Rate | Percentage of patients with a clinical response following RECIST (Response Evaluation Criteria in Solid Tumors) Criteria: Confirmed complete response(CR), Stable disease (SD), partial response (PR), or without progressive disease (PD). | Intent to treat | Posted | Number | 95% Confidence Interval | percentage of participants | at 6 months from study entry |
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Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
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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 | Arm I: CyberKnife Radiosurgery | Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery. | 3 | 50 | 34 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death not associated with CTCAE term - Disease progression NOS | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Bilirubin (hyperbilirubinemia) | Investigations | CTCAE (3.0) | Non-systematic Assessment | Additional adverse events associated with this hospitalization were: Grade 1 INR (International Normalized Ratio of prothrombin time) Grade 2 Liver dysfunction/failure (clinical) |
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| Confusion | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment | Confusion - Brain metastasis |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| "Fatigue (asthenia, lethargy, malaise)" | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pain - Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Edema: limb | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pain - Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pain - Chest wall | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Kunos | Case Comprehensive Cancer Center | 330-375-4485 | kunosc@summahealth.org |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |
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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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| 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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