Clinical trial NCT01079832: Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies
Official title: A Prospective Evaluation of a Palliative Radio-Surgical Approach for the Treatment of Gynecologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-03-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Acute Toxicity Rate
timeFrame: at 6 months after treatment
Secondary outcomes:
measure: Disease-free Survival
timeFrame: completion of study at 24 months
measure: Median Overall Survival
timeFrame: 24 months
measure: Quality of Life
timeFrame: After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
measure: Clinical Response Rate
timeFrame: at 6 months from study entry
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Robert DeBernardo, MD
role: PRINCIPAL_INVESTIGATOR
References: