Ignite Creation Date:
2024-05-06 @ 12:31 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03789149
Status:
TERMINATED
Last Update Posted:
2023-07-27
First Post:
2018-12-26
Brief Title:
Focal Intraoperative Radiotherapy of Brain Metastases
Sponsor:
AC Camargo Cancer Center
Organization:
AC Camargo Cancer Center
Study Overview
Official Title:
Focal Intraoperative Radiotherapy After Resection of Brain Metastases
Status:
TERMINATED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Planning to join a prospective multicentric trial after evaluation of 10 first participants
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 prevalent tumors of the central nervous system CNS with a ratio of 10 1 in relation to primary tumors In prospective studies whole-brain radiotherapy WBRT reduced the risk of local recurrence after resection of brain metastases from 46-59 to 10-28 Furthermore WBRT reduces the incidence of new metastases and death from disease but no apparent improvement in overall survival OS Due to the potential neurocognitive effects associated with WBRT compared to isolated focal approach several authors have suggested delaying WBRT and perform focal adjuvant RT after resection of isolated BM In this context intraoperative radiotherapy IORT in the cavity after resection of BM may be an appealing option
The primary objectives of this study are to evaluate local control LC and the control of brain disease LC associated with the absence of new distant BM after IORT for one completely resected supratentorial BM in the presence of up to 10 lesions suggestive of BM
The primary objectives of this study are to evaluate local control LC and the control of brain disease LC associated with the absence of new distant BM after IORT for one completely resected supratentorial BM in the presence of up to 10 lesions suggestive of BM
Detailed Description:
Brain metastases BM are the most prevalent tumors of the central nervous system CNS with a ratio of 10 1 in relation to primary tumors This type of metastasis occurs in 20-40 of cancer patients and are related to significant morbidity and mortality
In prospective studies whole-brain radiotherapy WBRT reduced the risk of local recurrence after resection of brain metastases from 46-59 to 10-28 Furthermore WBRT reduces the incidence of new metastases and death from disease but no apparent improvement in overall survival OS Due to the potential neurocognitive effects associated with WBRT compared to isolated focal approach several authors have suggested delaying WBRT and perform focal adjuvant RT after resection of isolated BM
The utilization of intraoperative radiotherapy IORT in the cavity after resection of primary or BM has been described in the literature the majority of reports describes performing brachytherapy with iodine seeds or interstitial radiosurgery However there is a paucity of information regarding the use of IORT with low energy X-ray for focal treatment after resection of brain BM
The objectives of this study are evaluate local control LC the control of brain disease in patients with metastatic brain disease up to 10 lesions submitted to focal IORT to an isolated surgical cavity evaluate overall survival OS evaluate the frequency of radiation necrosis and correlate the prognostic factors related to the patient with OS and the parameters of the treatment dose volume lesion location with the LC and radiation necrosis
In prospective studies whole-brain radiotherapy WBRT reduced the risk of local recurrence after resection of brain metastases from 46-59 to 10-28 Furthermore WBRT reduces the incidence of new metastases and death from disease but no apparent improvement in overall survival OS Due to the potential neurocognitive effects associated with WBRT compared to isolated focal approach several authors have suggested delaying WBRT and perform focal adjuvant RT after resection of isolated BM
The utilization of intraoperative radiotherapy IORT in the cavity after resection of primary or BM has been described in the literature the majority of reports describes performing brachytherapy with iodine seeds or interstitial radiosurgery However there is a paucity of information regarding the use of IORT with low energy X-ray for focal treatment after resection of brain BM
The objectives of this study are evaluate local control LC the control of brain disease in patients with metastatic brain disease up to 10 lesions submitted to focal IORT to an isolated surgical cavity evaluate overall survival OS evaluate the frequency of radiation necrosis and correlate the prognostic factors related to the patient with OS and the parameters of the treatment dose volume lesion location with the LC and radiation necrosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None