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

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment - Stereotactic Radiosurgery
Hide 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
Arm/Group Title Treatment - Stereotactic Radiosurgery
Hide 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
Hide 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%
1.Primary Outcome
Title Local Control
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment - Stereotactic Radiosurgery
Hide 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
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment - Stereotactic Radiosurgery
Hide 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   --/--    
Hide 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
Hide 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%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kathryn Beal
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-5159
EMail: bealk@mskcc.org
Layout table for additonal information
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