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NCT01079832 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2013-11-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Acute Toxicity Rate

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outcome · POSTED

Disease-free Survival

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outcome · POSTED

Median Overall Survival

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outcome · POSTED

Quality of Life

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outcome · POSTED

Clinical Response Rate

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
    intervention Names
    1. Radiation: stereotactic radiosurgery
    2. Procedure: quality-of-life assessment
    label
    Arm I: CyberKnife Radiosurgery
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I: CyberKnife Radiosurgery
    description
    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
    name
    stereotactic radiosurgery
    type
    RADIATION
  2. arm Group Labels
    1. Arm I: CyberKnife Radiosurgery
    description
    Ancillary studies
    name
    quality-of-life assessment
    other Names
    1. quality of life assessment
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
50
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.
    measure
    Acute Toxicity Rate
    time Frame
    at 6 months after treatment
secondary Outcomes
  1. description
    Median disease free survival
    measure
    Disease-free Survival
    time Frame
    completion of study at 24 months
  2. description
    Length of time patients survived at study end.
    measure
    Median Overall Survival
    time Frame
    24 months
  3. measure
    Quality of Life
    time Frame
    After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
  4. description
    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).
    measure
    Clinical Response Rate
    time Frame
    at 6 months from study entry
Full study description
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.
detailed 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.
Source references
Source notices and limitations
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice