Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT03789149 |
Other study ID # |
2315/17 |
Secondary ID |
|
Status |
Terminated |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
May 2, 2019 |
Est. completion date |
June 30, 2022 |
Study information
Verified date |
July 2022 |
Source |
AC Camargo Cancer Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.