Phase 2
Completed N=50
Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies
Source: ClinicalTrials.gov NCT01079832 ↗Enrolled (actual)
50
Serious AEs
6.0%
Results posted
Nov 2013
Primary outcomePrimary: Acute Toxicity Rate — 6 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Toxicity Rate |
6 | — |
| SECONDARY Disease-free Survival |
7.8 | — |
| SECONDARY Median Overall Survival |
20.2 | — |
| SECONDARY Quality of Life |
— | — |
| SECONDARY Clinical Response Rate |
68 | — |
Eligibility Criteria
Inclusion
- Pathologically proven gynecologic malignancy
- No prior cryosurgery or radiofrequency ablation, in target lesion
- Patient is able to give and sign study specific informed consent
- Measurable disease, according to RECIST criteria
- Laboratory parameters and appropriate clearance from anesthesia based on other medical co-morbidities for placement of fiducials; these would include CBC, basic metabolic panel, BUN, and creatinine
- >= 4 weeks from previous treatment (chemotherapy or radiation) of malignancy
- ECOG performance status of 0-3 as this procedure is minimally invasive and considered palliative in these patients
Exclusion
- Any patient with active connective tissue disease such as lupus or dermatomyositis is excluded
- Any patient with active Crohn's disease or active ulcerative colitis is excluded
- Major medical or psychiatric illness, which would prevent completion of treatment or interfere with follow-up is excluded
Data sourced from ClinicalTrials.gov (NCT01079832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.