Brain Metastases, Adult, Central Nervous System Metastases
Conditions
Keywords
Intraoperative Radiotherapy
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.
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.
Interventions
RADIATIONIntraoperative Radiotherapy
Intraoperative Radiotherapy with a mobile device (Intrabeam, Carl Zeiss AG) consisting of a small source of low energy x-rays (30-50 kV) mounted on a mechanical arm with six degrees of freedom. The resulting dose distribution is isotropic around the tip of the X-ray source. A set of spherical applicators with diameters ranging from 1.5 to 5 cm is available to connect to the source. The treatment time may vary from 20-30 minutes with the suggested dose of 18 Gy to the resection cavity to a depth of 1 mm.
Sponsors
Carl Zeiss Meditec AG
AC Camargo Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single group assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Histologically confirmed diagnosis of invasive cancer in the presence of up to 10 lesions suggestive of BM * Indication of resection of single lesion suggestive of BM and evidence of macroscopic complete resection * Patient consent to participate in the study
Exclusion criteria
* Previous cranial radiotherapy * Any kind of antineoplasic systemic treatment for less than 7 days of the procedure * Cavities with proximity \< 10 mm from the brainstem or optical pathway. * Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local control (LC) | 1 year | Rate of local failure in the surgical cavity |
| Control of Brain Disease (CBD) | 1 year | Rate of control in the brain outside |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 1 year | Rate of death related to any cause |
| Frequency of radiation necrosis | 1 year | Imaging evaluation |
Countries
Brazil
Outcome results
None listed