Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Evaluation of a Palliative Radio-Surgical Approach for the Treatment of Gynecologic Malignancies

Conditions
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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 IV Endometrial Carcinoma, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor, Stage IV Uterine Sarcoma, Stage IV Vulvar Cancer, Stage IVA Cervical Cancer, Stage IVA Vaginal Cancer, Stage IVB Cervical Cancer, Stage IVB Vaginal Cancer

Intervention / Treatment
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* Radiation: stereotactic radiosurgery
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I: CyberKnife Radiosurgery<br>Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery. | Radiation: stereotactic radiosurgery<br>* 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<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |