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

Primary Purpose

Fallopian Tube Cancer, Ovarian Sarcoma, Ovarian Stromal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
stereotactic radiosurgery
quality-of-life assessment
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I: CyberKnife Radiosurgery

Arm Description

Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.

Outcomes

Primary Outcome Measures

Acute Toxicity Rate
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
Median disease free survival
Median Overall Survival
Length of time patients survived at study end.
Quality of Life
Clinical Response Rate
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).

Full Information

First Posted
March 2, 2010
Last Updated
September 27, 2013
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01079832
Brief Title
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I: CyberKnife Radiosurgery
Arm Type
Experimental
Arm Description
Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiosurgery
Intervention Description
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
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Acute Toxicity Rate
Description
The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.
Time Frame
at 6 months after treatment
Secondary Outcome Measure Information:
Title
Disease-free Survival
Description
Median disease free survival
Time Frame
completion of study at 24 months
Title
Median Overall Survival
Description
Length of time patients survived at study end.
Time Frame
24 months
Title
Quality of Life
Time Frame
After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
Title
Clinical Response Rate
Description
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).
Time Frame
at 6 months from study entry

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert DeBernardo, MD
Organizational Affiliation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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