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A Prospective Evaluation of a Palliative Radio-Surgical Approach for the Treatment of Gynecologic Malignancies


Phase 2
18 Years
N/A
Not Enrolling
Female
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

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Trial Information

A Prospective Evaluation of a Palliative Radio-Surgical Approach for the Treatment of Gynecologic Malignancies


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Acute toxicity rate

Outcome Time Frame:

estimate the rate of grade 3 or higher acute toxicities observed during a 6 month period

Safety Issue:

Yes

Principal Investigator

Robert DeBernardo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CASE13808

NCT ID:

NCT01079832

Start Date:

May 2009

Completion Date:

May 2012

Related Keywords:

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

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065