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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
Enrollment 50

Recruitment Details Between July 24,2009 and September 7, 2011, 50 patients were recruited from University Hospitals in Cleveland Ohio.
Pre-assignment Details  
Arm/Group Title Arm I: CyberKnife Radiosurgery
Hide Arm/Group Description Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Period Title: Overall Study
Started 50
Completed 49
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Arm I: CyberKnife Radiosurgery
Hide Arm/Group Description Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 50 participants
66
(27 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
50
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
48
  96.0%
Unknown or Not Reported
2
   4.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  10.0%
White
45
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title Acute Toxicity Rate
Hide Description The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.
Time Frame at 6 months after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Arm I: CyberKnife Radiosurgery
Hide Arm/Group Description:
Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
6
2.Secondary Outcome
Title Disease-free Survival
Hide Description Median disease free survival
Time Frame completion of study at 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Arm I: CyberKnife Radiosurgery
Hide Arm/Group Description:
Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: months
7.8
(4 to 11.6)
3.Secondary Outcome
Title Median Overall Survival
Hide Description Length of time patients survived at study end.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Arm I: CyberKnife Radiosurgery
Hide Arm/Group Description:
Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: months
20.2
(10 to 29.5)
4.Secondary Outcome
Title Quality of Life
Hide Description [Not Specified]
Time Frame After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participant surveys were unreliably returned to investigators, making this analysis not meaningful.
Arm/Group Title Arm I: CyberKnife Radiosurgery
Hide Arm/Group Description:
Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Clinical Response Rate
Hide Description 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).
Time Frame at 6 months from study entry
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Arm I: CyberKnife Radiosurgery
Hide Arm/Group Description:
Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
68
(53 to 80)
Time Frame Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I: CyberKnife Radiosurgery
Hide Arm/Group Description Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
All-Cause Mortality
Arm I: CyberKnife Radiosurgery
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I: CyberKnife Radiosurgery
Affected / at Risk (%)
Total   3/50 (6.00%) 
General disorders   
Death not associated with CTCAE term - Disease progression NOS * 1  1/50 (2.00%) 
Investigations   
Bilirubin (hyperbilirubinemia) * 1 [1]  1/50 (2.00%) 
Nervous system disorders   
Confusion * 1 [2]  1/50 (2.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Additional adverse events associated with this hospitalization were: Grade 1 INR (International Normalized Ratio of prothrombin time) Grade 2 Liver dysfunction/failure (clinical)
[2]
Confusion - Brain metastasis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I: CyberKnife Radiosurgery
Affected / at Risk (%)
Total   34/50 (68.00%) 
Blood and lymphatic system disorders   
Hemoglobin * 1  6/34 (17.65%) 
Platelets * 1  3/34 (8.82%) 
Gastrointestinal disorders   
Diarrhea * 1  3/34 (8.82%) 
Nausea * 1  6/34 (17.65%) 
Pain - Abdomen NOS * 1  2/34 (5.88%) 
General disorders   
"Fatigue (asthenia, lethargy, malaise)" * 1  10/34 (29.41%) 
Edema: limb * 1  2/34 (5.88%) 
Metabolism and nutrition disorders   
Anorexia * 1  2/34 (5.88%) 
Creatinine * 1  2/34 (5.88%) 
Musculoskeletal and connective tissue disorders   
Pain - Back * 1  3/34 (8.82%) 
Pain - Chest wall * 1  2/34 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath) * 1  2/34 (5.88%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
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