Trials / Completed
CompletedNCT01079832
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Case Comprehensive Cancer Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
PRIMARY OBJECTIVES: I. The primary goal of this study is to estimate the rate of grade 3 or higher acute toxicities observed during a 6 month period following CyberKnife radiosurgery for gynecologic cancers. II. To evaluate clinical response to radio-surgery for gynecologic tumors. III. To assess general and site specific quality of life (using SF-12, FACT-En, FACT-O, FACT-Cx or FACT-V) and to evaluate patient's level of pain. SECONDARY OBJECTIVES: I. As a secondary objective, toxicities during the 2 years following CyberKnife radiosurgery will also be described. OUTLINE: Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery. After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
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
| Type | Name | Description |
|---|---|---|
| RADIATION | stereotactic radiosurgery | Radiation will be delivered in 3 fractions. The dose level will range between 500 to 800cGy per fraction at the discretion of the treating radiation oncologist |
| PROCEDURE | quality-of-life assessment | Ancillary studies |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2012-05-01
- Completion
- 2012-05-01
- First posted
- 2010-03-03
- Last updated
- 2013-11-28
- Results posted
- 2013-11-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01079832. Inclusion in this directory is not an endorsement.