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

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Completed; Phase 2

Conditions: Stage IVB Vaginal Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Cervical Cancer; Stage IV Ovarian Epithelial Cancer; Stage III Ovarian Germ Cell Tumor; Fallopian Tube Cancer; Stage III Vulvar Cancer; Stage III Ovarian Epithelial Cancer; Stage III Cervical Cancer; Stage IV Vulvar Cancer; Stage III Uterine Sarcoma; Recurrent Uterine Sarcoma; Recurrent Vulvar Cancer; Stage IVA Vaginal Cancer; Stage IVA Cervical Cancer; Recurrent Endometrial Carcinoma; Stage IV Uterine Sarcoma; Stage IV Endometrial Carcinoma; Recurrent Ovarian Epithelial Cancer; Stage IVB Cervical Cancer; Stage IV Ovarian Germ Cell Tumor; Recurrent Vaginal Cancer; Ovarian Stromal Cancer; Ovarian Sarcoma; Stage III Vaginal Cancer; Stage III Endometrial Carcinoma

Treatments: Procedure: quality-of-life assessment; Radiation: stereotactic radiosurgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01079832

NCI-2010-00285 (Other Identifier)

CASE13808 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Arm I: CyberKnife Radiosurgery

Experimental group

Description:

Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.

Treatment:

Procedure: quality-of-life assessment

Radiation: stereotactic radiosurgery