Trial Outcomes & Findings for Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies (NCT NCT01079832)

NCT ID: NCT01079832

Last Updated: 2013-11-28

Results Overview

The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: at 6 months after treatment
• Results posted on: 2013-11-28

Participant Flow

Between July 24,2009 and September 7, 2011, 50 patients were recruited from University Hospitals in Cleveland Ohio.

Participant milestones

Measure	Arm I: CyberKnife Radiosurgery Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Overall Study STARTED	50
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Arm I: CyberKnife Radiosurgery Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm I: CyberKnife Radiosurgery n=50 Participants Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Age Continuous	66 years n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: at 6 months after treatment

Population: Intent to treat

The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.

Outcome measures

Measure	Arm I: CyberKnife Radiosurgery n=50 Participants Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Acute Toxicity Rate	6 percentage of participants

SECONDARY outcome

Timeframe: completion of study at 24 months

Population: Intent to treat

Median disease free survival

Outcome measures

Measure	Arm I: CyberKnife Radiosurgery n=50 Participants Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Disease-free Survival	7.8 months Interval 4.0 to 11.6

SECONDARY outcome

Timeframe: 24 months

Population: Intent to treat

Length of time patients survived at study end.

Outcome measures

Measure	Arm I: CyberKnife Radiosurgery n=50 Participants Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Median Overall Survival	20.2 months Interval 10.0 to 29.5

SECONDARY outcome

Timeframe: After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.

Population: Participant surveys were unreliably returned to investigators, making this analysis not meaningful.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 6 months from study entry

Population: Intent to treat

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).

Outcome measures

Measure	Arm I: CyberKnife Radiosurgery n=50 Participants Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Clinical Response Rate	68 percentage of participants Interval 53.0 to 80.0

Adverse Events

Arm I: CyberKnife Radiosurgery

Serious events: 3 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I: CyberKnife Radiosurgery n=50 participants at risk Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
General disorders Death not associated with CTCAE term - Disease progression NOS	2.0% 1/50 • Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
Investigations Bilirubin (hyperbilirubinemia)	2.0% 1/50 • Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
Nervous system disorders Confusion	2.0% 1/50 • Adverse events were collected while patients were receiving treatment and during 6 months of follow up.

Other adverse events

Measure	Arm I: CyberKnife Radiosurgery n=50 participants at risk Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Blood and lymphatic system disorders Hemoglobin	17.6% 6/34 • Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
Blood and lymphatic system disorders Platelets	8.8% 3/34 • Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
General disorders "Fatigue (asthenia, lethargy, malaise)"	29.4% 10/34 • Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
Metabolism and nutrition disorders Anorexia	5.9% 2/34 • Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
Gastrointestinal disorders Diarrhea	8.8% 3/34 • Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
Gastrointestinal disorders Nausea	17.6% 6/34 • Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
Gastrointestinal disorders Pain - Abdomen NOS	5.9% 2/34 • Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
General disorders Edema: limb	5.9% 2/34 • Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
Metabolism and nutrition disorders Creatinine	5.9% 2/34 • Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
Musculoskeletal and connective tissue disorders Pain - Back	8.8% 3/34 • Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
Musculoskeletal and connective tissue disorders Pain - Chest wall	5.9% 2/34 • Adverse events were collected while patients were receiving treatment and during 6 months of follow up.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	5.9% 2/34 • Adverse events were collected while patients were receiving treatment and during 6 months of follow up.

Additional Information

Dr. Charles Kunos

Case Comprehensive Cancer Center

Phone: 330-375-4485

Email: kunosc@summahealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place