Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases

• ClinicalTrials.gov Identifier: NCT00587964
• Recruitment Status: Completed
• First Posted: January 8, 2008
• Results First Posted: February 22, 2016
• Last Update Posted: February 22, 2016
• Sponsor: Memorial Sloan Kettering Cancer Center
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Brain Metastasis; Bladder Cancer; Breast Cancer; Cervical Cancer; Colon Cancer; HEENT Cancer; Lung Cancer; Melanoma; Pancreatic Cancer; Prostate Cancer; Rectal Cancer; Sarcoma; Testicular Cancer
• Intervention: Radiation: Stereotactic Radiosurgery
• Enrollment: 51

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Treatment - Stereotactic Radiosurgery
Arm/Group Description	Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
Period Title: Overall Study
Started	51
Completed	39
Not Completed	12
Reason Not Completed
Withdrawal by Subject	1
Lost to Follow-up	1
Patient found to be ineligible	1
Patient did not receive intervention	5
Progression of Disease	4

Baseline Characteristics

Arm/Group Title		Treatment - Stereotactic Radiosurgery
Arm/Group Description		Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
Overall Number of Baseline Participants		51
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	51 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	34 66.7%
	>=65 years	17 33.3%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	51 participants
	Female	33 64.7%
	Male	18 35.3%

Outcome Measures

1. Primary Outcome

Title	Local Control
Description	following a combination of stereotactic radiosurgery and surgical resection for brain metastases; to determine the incidence of the brain injury following the combination therapy. Local control: Absence of radiographic evidence of tumor at the site of therapy constitutes local control of the treated disease.Recurrence in the treated region: The reappearance of tumor on any MRI or CT scan at the site of treatment constitutes recurrent disease at the treated region. Recurrence outside the treated region: The development of new intracranial metastatic foci or leptomeningeal disease constitutes recurrence outside the treated region. Leptomeningeal disease will be documented by a positive CSF cytology, abnormal myelogram or spinal MRI. No evidence of disease: Absence of clinical or radiographic evidence of tumor both at the site of therapy and elsewhere in the brain constitutes no evidence of disease.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment - Stereotactic Radiosurgery
Arm/Group Description:	Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
Overall Number of Participants Analyzed	39
Measure Type: Number; Unit of Measure: participants
Local Control	13
No Evidence of Disease (NED)	23
Progression of Disease (POD)	2
Relapse/Recurrence	1

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Treatment - Stereotactic Radiosurgery
Arm/Group Description	Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
All-Cause Mortality
	Treatment - Stereotactic Radiosurgery
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Treatment - Stereotactic Radiosurgery
	Affected / at Risk (%)	# Events
Total	16/51 (31.37%)
Blood and lymphatic system disorders
Blood disorder † 1	1/51 (1.96%)	1
Hypomagnesemia † 1	1/51 (1.96%)	1
Platelets count decrease † 1	1/51 (1.96%)	1
Cardiac disorders
Thrombosis † 1	1/51 (1.96%)	1
Eye disorders
Vision-blurred vision † 1	1/51 (1.96%)	1
Gastrointestinal disorders
Constipation † 1	1/51 (1.96%)	1
Radiation oesophagitis † 1	1/51 (1.96%)	1
Nausea † 1	2/51 (3.92%)	2
Vomiting † 1	2/51 (3.92%)	2
General disorders
General symptom † 1	2/51 (3.92%)	2
Headache † 1	1/51 (1.96%)	2
Musculoskeletal and connective tissue disorders
Bone pain † 1	1/51 (1.96%)	1
Nervous system disorders
Ischemia cerebrovascular † 1	1/51 (1.96%)	1
Confusion † 1	3/51 (5.88%)	3
Neurological disorder † 1	2/51 (3.92%)	2
Peripheral motor neuropathy † 1	1/51 (1.96%)	1
Seizure † 1	2/51 (3.92%)	3
Syncope † 1	1/51 (1.96%)	1
Respiratory, thoracic and mediastinal disorders
Pleural effusion † 1	2/51 (3.92%)	2
Respiratory disorder † 1	3/51 (5.88%)	3
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, CTC-2.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Treatment - Stereotactic Radiosurgery
	Affected / at Risk (%)	# Events
Total	0/51 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

Results Point of Contact

• Name/Title: Dr. Kathryn Beal
• Organization: Memorial Sloan Kettering Cancer Center
• Phone: 212-639-5159
• EMail: bealk@mskcc.org

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT00587964
• Other Study ID Numbers: 04-061
• First Submitted: December 26, 2007
• First Posted: January 8, 2008
• Results First Submitted: December 14, 2015
• Results First Posted: February 22, 2016
• Last Update Posted: February 22, 2016