Clinical trial NCT00983359: Stereotactic Radiation Therapy in Treating Patients With Brain Metastases
Official title: A Phase II Trial of Focal Therapy in the Treatment of Patients With 1-3 Brain Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: tumors metastatic to brain
unspecified adult solid tumor, protocol specific
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2009-09-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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 criteria: Inclusion Criteria:

* Histology-confirmed cancer with 1 to 3 symptomatic brain metastases imaged by MRI/CT scans.
* Have cancer not originating in central nervous system (CNS)
* Karnofsky score of at least 60
* Given written consent
* At least 18 years of age

Exclusion Criteria:

* Prior whole brain radiotherapy or prior focal radiotherapy of the metastasis/es considered for this trial.
* Certain radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.

Primary outcomes:
measure: Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status
timeFrame: Up to 5 years
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to 5 years
measure: Time to Neurological Death
timeFrame: From time of enrollment up to 5 years
measure: Time to Systemic Death
timeFrame: From time of enrollment up to 5 years
measure: Karnofsky Decay Time
timeFrame: From time of enrollment up to 5 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Mario Ammirati, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ammirati M, Kshettry VR, Lamki T, Wei L, Grecula JC. A prospective phase II trial of fractionated stereotactic intensity modulated radiotherapy with or without surgery in the treatment of patients with 1 to 3 newly diagnosed symptomatic brain metastases. Neurosurgery. 2014 Jun;74(6):586-94; discussion 594. doi: 10.1227/NEU.0000000000000325.