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

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ClinicalTrials.gov Identifier: NCT01079832
Recruitment Status : Completed
First Posted : March 3, 2010
Results First Posted : November 28, 2013
Last Update Posted : November 28, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment 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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of a Palliative Radio-Surgical Approach for the Treatment of Gynecologic Malignancies
Study Start Date : May 2009
Primary Completion Date : May 2012
Study Completion Date : May 2012


Arms and Interventions

Arm Intervention/treatment
Experimental: Arm I: CyberKnife Radiosurgery
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


Outcome Measures

Primary Outcome Measures :
  1. Acute Toxicity Rate [ Time Frame: at 6 months after treatment ]
    The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.


Secondary Outcome Measures :
  1. Disease-free Survival [ Time Frame: completion of study at 24 months ]
    Median disease free survival

  2. Median Overall Survival [ Time Frame: 24 months ]
    Length of time patients survived at study end.

  3. Quality of Life [ Time Frame: After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months. ]
  4. Clinical Response Rate [ Time Frame: at 6 months from study entry ]
    Percentage of patients with a clinical response following RECIST (Response Evaluation Criteria in Solid Tumors) Criteria: Confirmed complete response(CR), Stable disease (SD), partial response (PR), or without progressive disease (PD).


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01079832     History of Changes
Other Study ID Numbers: CASE13808
NCI-2010-00285 ( Other Identifier: NCI/CTRP )
CASE13808 ( Other Identifier: Case Comprehensive Cancer Center )
First Posted: March 3, 2010    Key Record Dates
Results First Posted: November 28, 2013
Last Update Posted: November 28, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endometrial Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective and Soft Tissue
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Vaginal Diseases
Carcinoma
Sarcoma
Germinoma
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Vulvar Diseases