Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-30 @ 6:42 AM
Study NCT ID:
NCT01079832
Status:
COMPLETED
Last Update Posted:
2013-11-28
First Post:
2010-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Prospective Evaluation of a Palliative Radio-Surgical Approach for the Treatment of Gynecologic Malignancies
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: