Brain Metastases, Adult Clinical Trial
Official title:
Focal Intraoperative Radiotherapy After Resection of Brain Metastases
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05428852 -
Keto-Brain:Investigating the Use of Ketogenic Diets in Brain Metastases
|
N/A | |
Recruiting |
NCT05559853 -
Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment
|
||
Recruiting |
NCT05689619 -
SILibinin in NSCLC and BC Patients With Single Brain METastasis (SILMET)
|
N/A | |
Recruiting |
NCT04197297 -
Brain Imaging Biomarkers in Patients With Brain Metastasis
|
Phase 2 | |
Recruiting |
NCT04397978 -
Local Ablative Therapy for Patients With Multiple (4-10) Brain Metastases
|
||
Terminated |
NCT04434560 -
Neoadjuvant Immunotherapy in Brain Metastases
|
Phase 2 | |
Active, not recruiting |
NCT05095766 -
Comparaison Between MRI Alone or Combined With Positron Emission Tomography for Brain Metastasis Diagnosis
|
||
Recruiting |
NCT05012254 -
Nivolumab and Ipilimumab Plus Chemotherapy for Patients With Stage IV Lung Cancer With Brain Metastases
|
Phase 2 | |
Recruiting |
NCT05789589 -
Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases
|
Phase 1/Phase 2 | |
Recruiting |
NCT06280300 -
Multi-disciplinary Care for Brain Metastases
|
N/A | |
Recruiting |
NCT06047379 -
Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
|
Phase 1/Phase 2 | |
Completed |
NCT03896555 -
Intrafractional Head Movement During Radiosurgery
|
||
Recruiting |
NCT04343157 -
UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases
|
Phase 2 | |
Recruiting |
NCT04711824 -
Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases
|
Phase 1/Phase 2 | |
Recruiting |
NCT05793489 -
Prospective Double Arm Randomized Trial: WBRT Alone and WBRT Plus Silibinin
|
N/A | |
Recruiting |
NCT04461418 -
Accelerated Checkpoint Therapy for Any Steroid Dependent Patient With Brain Metastases
|
Phase 2 | |
Active, not recruiting |
NCT03818386 -
Radiotherapy of Multiple Brain Metastases Using AGuIX®
|
Phase 2 | |
Active, not recruiting |
NCT05087095 -
Managing Distress in Malignant Brain Cancer
|
N/A | |
Recruiting |
NCT04396717 -
Safety Study of Pritumumab in Brain Cancer
|
Phase 1 | |
Recruiting |
NCT06231186 -
a Feasibility Study of iHD-SRT for BM
|
N/A |