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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01079832
Other study ID # CASE13808
Secondary ID NCI-2010-00285CA
Status Completed
Phase Phase 2
First received March 2, 2010
Last updated September 27, 2013
Start date May 2009
Est. completion date May 2012

Study information

Verified date September 2013
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Carcinoma
  • Endometrial Neoplasms
  • Fallopian Tube Cancer
  • Germinoma
  • Neoplasms, Germ Cell and Embryonal
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms
  • 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
  • Sarcoma
  • 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
  • Uterine Cervical Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms

Intervention

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

Locations

Country Name City State
United States Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute Toxicity Rate The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period. at 6 months after treatment Yes
Secondary Disease-free Survival Median disease free survival completion of study at 24 months No
Secondary Median Overall Survival Length of time patients survived at study end. 24 months No
Secondary Quality of Life After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months. No
Secondary 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). at 6 months from study entry No
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