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

Phase 2

Completed

• Conditions: Ovarian Stromal Cancer; Recurrent Cervical Cancer; Stage IV Vulvar Cancer; Stage IVA Vaginal Cancer; Stage IVB Cervical Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Uterine Sarcoma; Recurrent Vaginal Cancer; Recurrent Vulvar Cancer
• Interventions: Radiation: stereotactic radiosurgery; Procedure: quality-of-life assessment

• Registration Number: NCT01079832
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

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

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 Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2013-07-19
• Status Verified: 2013-09
• Results First Submitted QC: 2013-09-27
• Last Update Submitted: 2013-09-27
• Results First Posted: 2013-11-28
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I: CyberKnife Radiosurgery	stereotactic radiosurgery	Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Arm I: CyberKnife Radiosurgery	quality-of-life assessment	Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Quality of Life	After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
Median Overall Survival	24 months	Length of time patients survived at study end.
Disease-free Survival	completion of study at 24 months	Median disease free survival
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).

Trial Locations

Locations (1)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States