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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03139 | Registry Identifier | Clinical Trials Reporting Program (CTRP) |
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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
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (conformal stereotactic radiation therapy) | Experimental | Patients undergo conformal stereotatic radiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status | Neurological death is defined as dying with progressive neurological dysfunction regardless of systemic disease status. Patients wtih severe neurological disability who die of intercurrent illness will also be considered to have died of neurological death. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Time from enrollment to first date of progressive or recurrent disease. Worsening of neurological symptoms is considered indicative of neurological disease progression. Patients who die of disease-related or treatment-related causes will be considered to have progressed at their date of death; i.e., not be considered 'censored'. PFS will be considered censored only if no progression is noted or if the patient dies of a clearly non-cancer-related event such as accident. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Ammirati, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210-1240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24589560 | Result | 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. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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Patient recruitment period was June 2007 to March 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Conformal Stereotactic Radiation Therapy) | Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Conformal Stereotactic Radiation Therapy) | Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status | Neurological death is defined as dying with progressive neurological dysfunction regardless of systemic disease status. Patients wtih severe neurological disability who die of intercurrent illness will also be considered to have died of neurological death. | Posted | Number | patients | Up to 5 years |
|
|
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The NCI Common Terminology Criteria for Adverse Events version 3 [CTCAEv3] was used to access adverse events for patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Conformal Stereotactic Radiation Therapy) | Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mario Ammirati, MD | The Ohio State University Comprehensive Cancer Center | 614-293-1970 | Mario.Ammirati@osumc.edu |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
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|
| Up to 5 years |
| Time to Neurological Death | Time from enrollment to date of death directly due to brain metastases. Deaths from other causes including hemorrhage or infection will be considered 'censored' observations in the setting of neurologic improvement or stabilization. If the patient dies of any cause with worsening of neurologic symptoms, the death will be counted as an 'event' or neurological death. | From time of enrollment up to 5 years |
| Time to Systemic Death | Descriptive analysis will be conducted using Kaplan-Meier survival analysis | From time of enrollment up to 5 years |
| Karnofsky Decay Time | Time from enrollment to the date the patient's Karnofsky performance score drops below 60. If the patient dies of any cause with no documentation of a drop in their Karnofsky score to less than 60, the date of death will be used as the date of worsening of the Karnofsky score. A patient with a Karnofsky score of 60 or greater requires occasional assistance, but is able to care for most of his/her needs. A patient's Karnofsky decay time will be considered censored if the patient is still under follow up with a Karnofsky score of 60 or greater and if the patient dies of a non-cancer-related cause. | From time of enrollment up to 5 years |
| patients |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | patients |
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| Extracranial metastases | Number | patients |
|
| Number of brain metastases | Patients with ≥4 brain metastases were eligible for study if only 1 to 3 were symptomatic and all others asymptomatic. | Number | patients with brain metastases |
|
| Participants |
|
|
| Secondary | Progression-free Survival (PFS) | Time from enrollment to first date of progressive or recurrent disease. Worsening of neurological symptoms is considered indicative of neurological disease progression. Patients who die of disease-related or treatment-related causes will be considered to have progressed at their date of death; i.e., not be considered 'censored'. PFS will be considered censored only if no progression is noted or if the patient dies of a clearly non-cancer-related event such as accident. | Posted | Median | 95% Confidence Interval | months | Up to 5 years |
|
|
|
| Secondary | Time to Neurological Death | Time from enrollment to date of death directly due to brain metastases. Deaths from other causes including hemorrhage or infection will be considered 'censored' observations in the setting of neurologic improvement or stabilization. If the patient dies of any cause with worsening of neurologic symptoms, the death will be counted as an 'event' or neurological death. | Posted | Median | Full Range | months | From time of enrollment up to 5 years |
|
|
|
| Secondary | Time to Systemic Death | Descriptive analysis will be conducted using Kaplan-Meier survival analysis | Posted | Median | 95% Confidence Interval | months | From time of enrollment up to 5 years |
|
|
|
| Secondary | Karnofsky Decay Time | Time from enrollment to the date the patient's Karnofsky performance score drops below 60. If the patient dies of any cause with no documentation of a drop in their Karnofsky score to less than 60, the date of death will be used as the date of worsening of the Karnofsky score. A patient with a Karnofsky score of 60 or greater requires occasional assistance, but is able to care for most of his/her needs. A patient's Karnofsky decay time will be considered censored if the patient is still under follow up with a Karnofsky score of 60 or greater and if the patient dies of a non-cancer-related cause. | Posted | Median | Full Range | months | From time of enrollment up to 5 years |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
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| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |