Fallopian Tube Cancer, Ovarian Sarcoma, Ovarian Stromal Cancer, Recurrent Cervical Cancer, Recurrent Endometrial Carcinoma, Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent Uterine Sarcoma, Recurrent Vaginal Cancer, Recurrent Vulvar Cancer, Stage III Cervical Cancer, Stage III Endometrial Carcinoma, Stage III Ovarian Epithelial Cancer, Stage III Ovarian Germ Cell Tumor, Stage III Uterine Sarcoma, Stage III Vaginal Cancer, Stage III Vulvar Cancer, Stage IVA Cervical Cancer, Stage IVA Vaginal Cancer, Stage IVB Cervical Cancer, Stage IVB Vaginal Cancer, Stage IV Endometrial Carcinoma, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor, Stage IV Uterine Sarcoma, Stage IV Vulvar Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONstereotactic radiosurgery
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
PROCEDUREquality-of-life assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion * Pathologically proven gynecologic malignancy * No prior cryosurgery or radiofrequency ablation, in target lesion * Patient is able to give and sign study specific informed consent * Measurable disease, according to RECIST criteria * Laboratory parameters and appropriate clearance from anesthesia based on other medical co-morbidities for placement of fiducials; these would include CBC, basic metabolic panel, BUN, and creatinine * \>= 4 weeks from previous treatment (chemotherapy or radiation) of malignancy * ECOG performance status of 0-3 as this procedure is minimally invasive and considered palliative in these patients Exclusion * Any patient with active connective tissue disease such as lupus or dermatomyositis is excluded * Any patient with active Crohn's disease or active ulcerative colitis is excluded * Major medical or psychiatric illness, which would prevent completion of treatment or interfere with follow-up is excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Toxicity Rate | at 6 months after treatment | The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival | completion of study at 24 months | Median disease free survival |
| Median Overall Survival | 24 months | Length of time patients survived at study end. |
| Quality of Life | After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months. | — |
| Clinical Response Rate | at 6 months from study entry | 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). |
Countries
United States
Participant flow
Recruitment details
Between July 24,2009 and September 7, 2011, 50 patients were recruited from University Hospitals in Cleveland Ohio.
Participants by arm
| Arm | Count |
|---|---|
| Arm I: CyberKnife Radiosurgery Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Arm I: CyberKnife Radiosurgery |
|---|---|
| Age Continuous | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 34 / 50 |
| serious Total, serious adverse events | 3 / 50 |
Outcome results
Primary
Acute Toxicity Rate
The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.
Time frame: at 6 months after treatment
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I: CyberKnife Radiosurgery | Acute Toxicity Rate | 6 percentage of participants |
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).
Time frame: at 6 months from study entry
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I: CyberKnife Radiosurgery | Clinical Response Rate | 68 percentage of participants |
Secondary
Disease-free Survival
Median disease free survival
Time frame: completion of study at 24 months
Population: Intent to treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I: CyberKnife Radiosurgery | Disease-free Survival | 7.8 months |
Secondary
Median Overall Survival
Length of time patients survived at study end.
Time frame: 24 months
Population: Intent to treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I: CyberKnife Radiosurgery | Median Overall Survival | 20.2 months |
Secondary
Quality of Life
Time frame: After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
Population: Participant surveys were unreliably returned to investigators, making this analysis not meaningful.