Clinical trial · Interventional
Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies
A Prospective Evaluation of a Palliative Radio-Surgical Approach for the Treatment of Gynecologic Malignancies
NCT01079832CI-TRIAL-00012775completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (26)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Sarcoma | Ovarian Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Stromal Cancer | Malignant Ovarian Epithelial Tumor | ALIAS | 0.90 |
| Recurrent Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Endometrial Carcinoma | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Ovarian Epithelial Cancer | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Ovarian Germ Cell Tumor | Ovarian Germ Cell Tumor | CURATED_BROADER | 0.78 |
| Recurrent Uterine Sarcoma | Uterine Corpus Sarcoma | CURATED_BROADER | 0.78 |
| Recurrent Vaginal Cancer |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I: CyberKnife Radiosurgery
- description
- Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
- interventionNames
- Radiation: stereotactic radiosurgery
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- Acute Toxicity Rate
- timeFrame
- at 6 months after treatment
- description
- The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.
Secondary outcomes (4)
- measure
- Disease-free Survival
- timeFrame
- completion of study at 24 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.