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Completed

NCT Number: NCT01079832

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

quality-of-life assessment

Procedure

Ancillary studies

Other names: quality of life assessment

Primary outcomes

  1. Acute Toxicity Rate

    Time frame: at 6 months after treatment

    The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.

Secondary outcomes

  1. Disease-free Survival

    Time frame: completion of study at 24 months

    Median disease free survival

  2. Median Overall Survival

    Time frame: 24 months

    Length of time patients survived at study end.

  3. Quality of Life

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

  4. Clinical Response Rate

    Time frame: at 6 months from study entry

    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).

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 3, 2010
Registry last updated
Nov 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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