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
Recruitment status was Recruiting
Sponsor:
Ohio State University Comprehensive Cancer Center
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
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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) |
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
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 Neoplasms, Second Primary Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013