Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484978
Status:
UNKNOWN
Last Update Posted:
2007-06-12
First Post:
2007-06-11
Brief Title:
Stereotactic Radiosurgery to the Resection Cavity Following Surgical Removal of Brain Metastasis
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
A Single Center Prospective Phase II Study Stereotactic Radiosurgery to the Resection Cavity Following Surgical Removal of Brain Metastasis
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Brain metastases BM are the most common intracranial tumors in adults and source of the most common neurological complications of systemic cancer Surgery and radiation therapy are the most important components in the management of BM with the goal to prolong survival and improve the quality of life Whole brain radiotherapy WBRT has shown to increase local and distant control both with and without surgical resection However patients who develop a new or recurrent BM after WBRT and undergo resection are left without adjuvant therapy options Local recurrence particular in patients with single metastasis does effect both survival and quality of life In individual cases the option of additional radiotherapy has been suggested and applied We seek to evaluate the addition of a stereotactic radiosurgery SRS boost to the resection cavity both as adjuvant and salvage procedure among patients who undergo resection of a BM and previously received WBRT or decline WBRT Goal is to show superior local brain control
Detailed Description:
Study Purpose
Treatment strategies for recurrent brain metastasis
Limited clinical data support interventions for recurrent BM such as WBRT re-operation or SRS depending on previous treatments 6 45 48 Two retrospective analyses looked at a total of 130 non-small cell lung cancer NSCLC patients with recurrent BM after resection 6 45 Recurrence happened at the original site in approximately twothirds of the patients and at other sites for the remainders Re-resection had a significant effect on prolonged survival compared to patients who did not undergo it p0001 A small subgroup of these patients underwent a third resection with a median survival of 42 months A more recent study looked at resection of BM that had previously been treated with SRS 48 Sixty-one patients with 1-3 previously treated BM recurred and underwent resection Major neurological morbidity occurred in 2 and no mortality was observed A multivariate analysis showed that higher RPA class focal treatment surgery or SRS and treatment of new additional lesions significantly affected survival Re-operation of a previously focally treated BM provided long-term control and positive impact on survival Additionally confirming the pathological diagnosis in a recurrent lesion after SRS is important as radiation necrosis can occur in 23-86 of the patients a condition that requires a different treatment approach than that for recurrent metastasis 5 10 14
Surgery and radiation therapy are important components in the complex treatment of BM and can prolong survival and improve the quality of life Patients who develop brain metastasis after WBRT remain with limited options A resection will diminish the local disease significantly however adjuvant radiation might further increase the control rate We plan to evaluate the addition of a stereotactic radiosurgery SRS boost to the resection cavity both as adjuvant and salvage procedure in patient who underwent resection of a BM and previously received WBRT or decline WBRT
Study Design
The study is designed to observe patients for feasibility efficacy and toxicity
Patient Enrollment Informed Consent will be obtained and then eligibility screening will be assessed using Inclusion Exclusion criteria A patient who appears to meet ALL eligibility requirements will be asked to participate in the study
Variables Measured The primary end point will be evaluated following obtaining follow up neuro-imaging contrast Brain CT or MRI
The secondary end points will be measured as follows
Evaluation of CT and MRI by neuro-radiologist - Individual response comparison between pre-treatment and follow-up MRI performed at 2-3 months intervals or according to clinical indication
Side effects during and following the treatment as well as self reported or otherwise obtained absence of side effects
Pre-Procedure
Screening process
Patients with known systemic malignancy who underwent surgical resection of a brain metastasis and fulfill the eligibility criteria specified for this study see inclusionexclusion criteria
Imaging
All patients will undergo a contrast CT and MRI brain imaging in preparation of the treatment
Neurological Baseline Assessment
A standard neurological baseline examination shall take place The neurological examination will include the following
Cognitive function Mini Mental Status
Cranial nerves
Motor Strength
Deep tendon reflexes
Plantar response
Sensory
CoordinationGait
Treatment strategies for recurrent brain metastasis
Limited clinical data support interventions for recurrent BM such as WBRT re-operation or SRS depending on previous treatments 6 45 48 Two retrospective analyses looked at a total of 130 non-small cell lung cancer NSCLC patients with recurrent BM after resection 6 45 Recurrence happened at the original site in approximately twothirds of the patients and at other sites for the remainders Re-resection had a significant effect on prolonged survival compared to patients who did not undergo it p0001 A small subgroup of these patients underwent a third resection with a median survival of 42 months A more recent study looked at resection of BM that had previously been treated with SRS 48 Sixty-one patients with 1-3 previously treated BM recurred and underwent resection Major neurological morbidity occurred in 2 and no mortality was observed A multivariate analysis showed that higher RPA class focal treatment surgery or SRS and treatment of new additional lesions significantly affected survival Re-operation of a previously focally treated BM provided long-term control and positive impact on survival Additionally confirming the pathological diagnosis in a recurrent lesion after SRS is important as radiation necrosis can occur in 23-86 of the patients a condition that requires a different treatment approach than that for recurrent metastasis 5 10 14
Surgery and radiation therapy are important components in the complex treatment of BM and can prolong survival and improve the quality of life Patients who develop brain metastasis after WBRT remain with limited options A resection will diminish the local disease significantly however adjuvant radiation might further increase the control rate We plan to evaluate the addition of a stereotactic radiosurgery SRS boost to the resection cavity both as adjuvant and salvage procedure in patient who underwent resection of a BM and previously received WBRT or decline WBRT
Study Design
The study is designed to observe patients for feasibility efficacy and toxicity
Patient Enrollment Informed Consent will be obtained and then eligibility screening will be assessed using Inclusion Exclusion criteria A patient who appears to meet ALL eligibility requirements will be asked to participate in the study
Variables Measured The primary end point will be evaluated following obtaining follow up neuro-imaging contrast Brain CT or MRI
The secondary end points will be measured as follows
Evaluation of CT and MRI by neuro-radiologist - Individual response comparison between pre-treatment and follow-up MRI performed at 2-3 months intervals or according to clinical indication
Side effects during and following the treatment as well as self reported or otherwise obtained absence of side effects
Pre-Procedure
Screening process
Patients with known systemic malignancy who underwent surgical resection of a brain metastasis and fulfill the eligibility criteria specified for this study see inclusionexclusion criteria
Imaging
All patients will undergo a contrast CT and MRI brain imaging in preparation of the treatment
Neurological Baseline Assessment
A standard neurological baseline examination shall take place The neurological examination will include the following
Cognitive function Mini Mental Status
Cranial nerves
Motor Strength
Deep tendon reflexes
Plantar response
Sensory
CoordinationGait
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None