Focal Intraoperative Radiotherapy of Brain Metastases

Phase 2

Terminated

• Conditions: Central Nervous System Metastases; Brain Metastases, Adult
• Interventions: Radiation: Intraoperative Radiotherapy

• Registration Number: NCT03789149
• Lead Sponsor: AC Camargo Cancer Center

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.

Study Timeline

• Study First Submitted: 2018-12-26
• Study First Submitted QC: 2018-12-26
• Study First Posted: 2018-12-28
• Study Start: 2019-05-02
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoperative Radiotherapy	Intraoperative Radiotherapy	Intraoperative Radiotherapy with a mobile device (Intrabeam, Carl Zeiss AG)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Frequency of radiation necrosis	1 year	Imaging evaluation
Overall Survival (OS)	1 year	Rate of death related to any cause

Trial Locations

Locations (1)

AC Camargo Cancer Center; 🇧🇷 São Paulo, SP, Brazil