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

Case Comprehensive Cancer Center50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fallopian Tube Cancer Ovarian Sarcoma Ovarian Stromal Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Disease-free Survival

Median disease free survival

Time frame: completion of study at 24 months

Median Overall Survival

Length of time patients survived at study end.

Time frame: 24 months

Quality of Life

Time frame: 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).

Time frame: at 6 months from study entry