Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

A Phase II Trial of Focal Therapy in the Treatment of Patients With 1-3 Brain Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00983359
• Other study ID #: CDR0000654129
• Secondary ID: OSU-06138
• Status: Recruiting
• Phase: Phase 2
• First received: September 23, 2009
• Last updated: February 2, 2010
• Start date: April 2007

Study information

• Verified date: September 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Radiation:
• stereotactic radiosurgery

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological death rate			No
Secondary	Overall survival			No
Secondary	Progression-free survival rate or brain metastases recurrence rate at 6 months			No
Secondary	Time to neurological death			No
Secondary	Time to systemic death			No
Secondary	Karnofsky decay time			No
Secondary	Frequency and severity of adverse events			Yes