Stereotactic Radiosurgery Using CyberKnife 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.

• stereotactic radiosurgery (Radiation): 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
• quality-of-life assessment (Procedure), also known as quality of life assessment: Ancillary studies

Primary outcomes

• 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 outcomes

• 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).

Sex: Female, ages: 18 Years to any

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

Participant flow

Outcome results

• Acute Toxicity Rate (Primary), Number, percentage of participants: Arm I: CyberKnife Radiosurgery 6
• Disease-free Survival (Secondary), Median, months: Arm I: CyberKnife Radiosurgery 7.8 (4 to 11.6)
• Median Overall Survival (Secondary), Median, months: Arm I: CyberKnife Radiosurgery 20.2 (10 to 29.5)
• Quality of Life (Secondary)
• Clinical Response Rate (Secondary), Number, percentage of participants: Arm I: CyberKnife Radiosurgery 68 (53 to 80)

Adverse events

Time frame: Adverse events were collected while patients were receiving treatment and during 6 months of follow up.

Serious adverse events by term

Other adverse events by term

• Robert DeBernardo, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center