Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

• Sponsor: Ohio State University Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00983359
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 64
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific	Radiation: Radiation Therapy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Focal Therapy in the Treatment of Patients With 1-3 Brain Metastases
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (conformal stereotactic radiation therapy) Patients undergo conformal stereotatic radiation	Radiation: Radiation Therapy; Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.; Other Names: Radiation

Outcome Measures

Primary Outcome Measures

1. Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status [Up to 5 years]

   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.

Secondary Outcome Measures

1. Progression-free Survival (PFS) [Up to 5 years]

   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.

2. Time to Neurological Death [From time of enrollment up to 5 years]

   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.

3. Time to Systemic Death [From time of enrollment up to 5 years]

   Descriptive analysis will be conducted using Kaplan-Meier survival analysis

4. Karnofsky Decay Time [From time of enrollment up to 5 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210-1240

Sponsors and Collaborators

• Ohio State University Comprehensive Cancer Center

Investigators

• Principal Investigator: Mario Ammirati, MD, Ohio State University Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The Jamesline

Publications

None provided.

• Responsible Party: Mario Ammirati, Principal Investigator, Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT00983359
• Other Study ID Numbers: OSU-06138; NCI-2011-03139
• First Posted: Sep 24, 2009
• Last Update Posted: Jun 6, 2017
• Last Verified: May 1, 2017

• Keywords provided by Mario Ammirati, Principal Investigator, Ohio State University Comprehensive Cancer Center: tumors metastatic to brain; unspecified adult solid tumor, protocol specific
• Additional relevant MeSH terms: Brain Neoplasms

Study Results

Participant Flow

Recruitment Details	Patient recruitment period was June 2007 to March 2010

Arm/Group Title	Treatment (Conformal Stereotactic Radiation Therapy)
Arm/Group Description	Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Period Title: Overall Study
STARTED	40
Not Eligible for Analysis	1
COMPLETED	39
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Treatment (Conformal Stereotactic Radiation Therapy)
Arm/Group Description	Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Overall Participants	39
Age, Customized (patients) [Number]
≤60	20
>60	19
Sex: Female, Male (Count of Participants)
Female	17 43.6%
Male	22 56.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	39 100%
Unknown or Not Reported	0 0%
Region of Enrollment (patients) [Number]
United States	39
Extracranial metastases (patients) [Number]
Absent	19
Present	20
Number of brain metastases (patients with brain metastases) [Number]
1	25
2	4
3	8
≥4	2

Outcome Measures

1. Primary Outcome

Title	Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status
Description	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.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Conformal Stereotactic Radiation Therapy)
Arm/Group Description	Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Measure Participants	39
Number [patients]	5

2. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	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.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Conformal Stereotactic Radiation Therapy)
Arm/Group Description	Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Measure Participants	39
Median (95% Confidence Interval) [months]	11

3. Secondary Outcome

Title	Time to Neurological Death
Description	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.
Time Frame	From time of enrollment up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Conformal Stereotactic Radiation Therapy)
Arm/Group Description	Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Measure Participants	5
Median (Full Range) [months]	13

4. Secondary Outcome

Title	Time to Systemic Death
Description	Descriptive analysis will be conducted using Kaplan-Meier survival analysis
Time Frame	From time of enrollment up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Conformal Stereotactic Radiation Therapy)
Arm/Group Description	Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Measure Participants	39
Median (95% Confidence Interval) [months]	16

5. Secondary Outcome

Title	Karnofsky Decay Time
Description	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.
Time Frame	From time of enrollment up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Conformal Stereotactic Radiation Therapy)
Arm/Group Description	Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Measure Participants	39
Median (Full Range) [months]	14

Adverse Events

Adverse Event Reporting Description	The NCI Common Terminology Criteria for Adverse Events version 3 [CTCAEv3] was used to access adverse events for patients.
Arm/Group Title	Treatment (Conformal Stereotactic Radiation Therapy)
Arm/Group Description	Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
All Cause Mortality
	Treatment (Conformal Stereotactic Radiation Therapy)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment (Conformal Stereotactic Radiation Therapy)
	Affected / at Risk (%)	# Events
Total	0/39 (0%)
Other (Not Including Serious) Adverse Events
	Treatment (Conformal Stereotactic Radiation Therapy)
	Affected / at Risk (%)	# Events
Total	0/39 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.