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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01079832
First received: March 2, 2010
Last updated: September 27, 2013
Last verified: September 2013
  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:


Further study details as provided by Case Comprehensive Cancer Center:

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


Secondary Outcome Measures:
  • Disease-free Survival [ Time Frame: completion of study at 24 months ] [ Designated as safety issue: No ]
    Median disease free survival

  • Median Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Length of time patients survived at study end.

  • 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 ]
  • Clinical Response Rate [ Time Frame: at 6 months from study entry ] [ Designated as safety issue: No ]
    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).


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Results First Received: July 19, 2013
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 23, 2014