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

Fallopian Tube Cancer Clinical Trial

Official title:

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

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