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

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

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.

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