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

NCT01079832 | Completed Phase 2 Results DMC

• 2 other identifiers: CASE13808NCI-2010-00285
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Disease-free Survival

  completion of study at 24 months

• Median Overall Survival

  24 months

• Quality of Life

  After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.

• Clinical Response Rate

  at 6 months from study entry

Study Arms (1)

Arm I: CyberKnife Radiosurgery

EXPERIMENTAL

Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.

Radiation: stereotactic radiosurgery; Procedure: quality-of-life assessment

Interventions

stereotactic radiosurgery RADIATION

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

Arm I: CyberKnife Radiosurgery

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Arm I: CyberKnife Radiosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Carcinoma, Ovarian Epithelial; Vaginal Neoplasms; Vulvar Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Vaginal Diseases; Vulvar Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Charles Kunos
• Organization: Case Comprehensive Cancer Center

kunosc@summahealth.org

330-375-4485

Study Officials

• Robert DeBernardo, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: May 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 28, 2013
• Results First Posted: November 28, 2013

Record last verified: 2013-09

Locations

US (1)