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

NCT ID: NCT01079832

Last Updated: 2013-11-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-05-31

Brief Summary

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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

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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

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I: CyberKnife Radiosurgery

Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.

Group Type EXPERIMENTAL

stereotactic radiosurgery

Intervention Type RADIATION

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

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

Interventions

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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

Intervention Type RADIATION

quality-of-life assessment

Ancillary studies

Intervention Type PROCEDURE

Other Intervention Names

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quality of life assessment

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert DeBernardo, MD

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2010-00285

Identifier Type: OTHER

Identifier Source: secondary_id

CASE13808

Identifier Type: OTHER

Identifier Source: secondary_id

CASE13808

Identifier Type: -

Identifier Source: org_study_id