Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00983359
First received: September 23, 2009
Last updated: February 2, 2010
Last verified: September 2009
  Purpose

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase II trial is study how well stereotactic radiation therapy works in treating patients with brain metastases


Condition Intervention Phase
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Radiation: stereotactic radiosurgery
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Focal Therapy in the Treatment of Patients With 1-3 Brain Metastases

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Neurological death rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival rate or brain metastases recurrence rate at 6 months [ Designated as safety issue: No ]
  • Time to neurological death [ Designated as safety issue: No ]
  • Time to systemic death [ Designated as safety issue: No ]
  • Karnofsky decay time [ Designated as safety issue: No ]
  • Frequency and severity of adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: April 2007
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the neurological death rate following the initiation of conformal stereotactic radiotherapy in patients with 1-3 brain metastases.

Secondary

  • To determine the overall survival rate at 6 months.
  • To determine the progression-free survival rate or brain metastases recurrence rate at 6 months.
  • To determine the time to neurological death, time to systemic death, and Karnofsky decay time.
  • To determine the frequency and severity of adverse events associated with conformal stereotactic radiotherapy.

OUTLINE: Patients undergo conformal stereotactic radiotherapy over 5 days to an area including 3 mm around the metastases or the surgical cavity. Patients may receive additional radiotherapy if symptomatic metastases emerge at different sites.

After completion of study treatment, patients are followed up at 1 and 2 months and then every 3 months thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed cancer

    • Has 1-3 brain metastases, as evidenced by MRI/CT scan within the past 28 days, that are clinically symptomatic (any signs and/or symptoms are related to the metastases) or neurologically symptomatic (mass effect and/or brain shift)
  • No primary CNS cancer
  • No radiosensitive primary tumors, including any of the following:

    • Small cell lung cancer
    • Germ cell tumors
    • Lymphoma
    • Leukemia
    • Multiple myeloma

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%

PRIOR CONCURRENT THERAPY:

  • No prior whole brain radiotherapy or focal radiotherapy to the metastases considered for this study
  • Prior surgery to remove the tumor allowed provided it was completed within the past 28 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983359

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service    866-627-7616    osu@emergingmed.com   
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Mario Ammirati, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Mario Ammirati, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00983359     History of Changes
Other Study ID Numbers: CDR0000654129, OSU-06138
Study First Received: September 23, 2009
Last Updated: February 2, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
tumors metastatic to brain
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014