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

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ClinicalTrials.gov Identifier: NCT01079832
Recruitment Status : Completed
First Posted : March 3, 2010
Results First Posted : November 28, 2013
Last Update Posted : November 28, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Fallopian Tube Cancer
Ovarian Sarcoma
Ovarian Stromal Cancer
Recurrent Cervical Cancer
Recurrent Endometrial Carcinoma
Recurrent Ovarian Epithelial Cancer
Recurrent Ovarian Germ Cell Tumor
Recurrent Uterine Sarcoma
Recurrent Vaginal Cancer
Recurrent Vulvar Cancer
Stage III Cervical Cancer
Stage III Endometrial Carcinoma
Stage III Ovarian Epithelial Cancer
Stage III Ovarian Germ Cell Tumor
Stage III Uterine Sarcoma
Stage III Vaginal Cancer
Stage III Vulvar Cancer
Stage IV Endometrial Carcinoma
Stage IV Ovarian Epithelial Cancer
Stage IV Ovarian Germ Cell Tumor
Stage IV Uterine Sarcoma
Stage IV Vulvar Cancer
Stage IVA Cervical Cancer
Stage IVA Vaginal Cancer
Stage IVB Cervical Cancer
Stage IVB Vaginal Cancer
Interventions: Radiation: stereotactic radiosurgery
Procedure: quality-of-life assessment

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between July 24,2009 and September 7, 2011, 50 patients were recruited from University Hospitals in Cleveland Ohio.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I: CyberKnife Radiosurgery Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.

Participant Flow:   Overall Study
    Arm I: CyberKnife Radiosurgery
STARTED   50 
COMPLETED   49 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I: CyberKnife Radiosurgery Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.

Baseline Measures
   Arm I: CyberKnife Radiosurgery 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Years]
Median (Full Range)
 66 
 (27 to 82) 
Gender 
[Units: Participants]
 
Female   50 
Male   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   48 
Unknown or Not Reported   2 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   5 
White   45 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   50 


  Outcome Measures

1.  Primary:   Acute Toxicity Rate   [ Time Frame: at 6 months after treatment ]

2.  Secondary:   Disease-free Survival   [ Time Frame: completion of study at 24 months ]

3.  Secondary:   Median Overall Survival   [ Time Frame: 24 months ]

4.  Secondary:   Quality of Life   [ Time Frame: After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months. ]

5.  Secondary:   Clinical Response Rate   [ Time Frame: at 6 months from study entry ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Charles Kunos
Organization: Case Comprehensive Cancer Center
phone: 330-375-4485
e-mail: kunosc@summahealth.org



Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01079832     History of Changes
Other Study ID Numbers: CASE13808
NCI-2010-00285 ( Other Identifier: NCI/CTRP )
CASE13808 ( Other Identifier: Case Comprehensive Cancer Center )
First Submitted: March 2, 2010
First Posted: March 3, 2010
Results First Submitted: July 19, 2013
Results First Posted: November 28, 2013
Last Update Posted: November 28, 2013