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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01079832
• Date of registration: 02/03/2010
• Primary sponsor: Case Comprehensive Cancer Center
• Public title: Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies
• Scientific title: A Prospective Evaluation of a Palliative Radio-Surgical Approach for the Treatment of Gynecologic Malignancies
• Date of first enrolment: May 2009
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01079832
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Robert DeBernardo, MD
• Affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Procedure: quality-of-life assessment

Radiation: stereotactic radiosurgery

Primary Outcome(s)

Acute toxicity rate [Time Frame: estimate the rate of grade 3 or higher acute toxicities observed during a 6 month period]

Secondary Outcome(s)

Disease-free survival [Time Frame: Followed at 1, 3, 6, 12, 18 and 24 months, to the date of documentation of disease progression or until the date of death from any cause]

Overall survival [Time Frame: Followed at 1, 3, 6, 12, 18 and 24 months, to the date of documentation of disease progression or until the date of death from any cause]

Quality of life [Time Frame: After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.]

Secondary ID(s)

CASE13808

NCI-2010-00285

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)