Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies - Full Text View

Sponsor:	Case Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT01079832

Purpose

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.

Condition	Intervention	Phase
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	Radiation: stereotactic radiosurgery Procedure: quality-of-life assessment	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective Evaluation of a Palliative Radio-Surgical Approach for the Treatment of Gynecologic Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer Soft Tissue Sarcoma Vaginal Cancer Vulvar Cancer

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:

Acute toxicity rate [ Time Frame: estimate the rate of grade 3 or higher acute toxicities observed during a 6 month period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Disease-free survival [ Time Frame: Followed at 1, 3, 6, 12, 18 and 24 months, to the date of documentation of disease progression or until the date of death from any cause ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Followed at 1, 3, 6, 12, 18 and 24 months, to the date of documentation of disease progression or until the date of death from any cause ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months. ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	May 2009
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.	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 Other Name: quality of life assessment

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079832

Locations

United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Robert DeBernardo, MD

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

More Information

No publications provided

Responsible Party:	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT01079832 History of Changes
Other Study ID Numbers:	CASE13808, NCI-2010-00285, CASE13808
Study First Received:	March 2, 2010
Last Updated:	September 9, 2011
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Carcinoma
Uterine Cervical Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Germ Cell and Embryonal
Germinoma
Ovarian Neoplasms
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Sarcoma
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female

Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vaginal Diseases
Vulvar Diseases
Fallopian Tube Diseases
Adnexal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on May 24, 2012