Focal Intraoperative Radiotherapy of Brain Metastases

NCT03789149 | Terminated Phase 2 DMC

• 1 other identifier: 2315/17
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases, Adult; Central Nervous System Metastases

Keywords

Intraoperative Radiotherapy

Outcome Measures

Primary Outcomes (2)

• Local control (LC)

  Rate of local failure in the surgical cavity

  1 year

• Control of Brain Disease (CBD)

  Rate of control in the brain outside

  1 year

Secondary Outcomes (2)

• Overall Survival (OS)

  1 year

• Frequency of radiation necrosis

  1 year

Study Arms (1)

Intraoperative Radiotherapy

EXPERIMENTAL

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

Radiation: Intraoperative Radiotherapy

Interventions

Intraoperative Radiotherapy RADIATION

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.

Also known as: Intrabeam

Intraoperative Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AC Camargo Cancer Center: lead
• Carl Zeiss Meditec AG: collaborator

Study Sites (1)

AC Camargo Cancer Center

São Paulo, São Paulo, 01509-900, Brazil

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Douglas G Castro, MD

  AC Camargo Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group assignment

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 28, 2018
• Study Start: May 2, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 27, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 6 months after publication
• Access Criteria: Correlated Area Investigators with publishing background and a defined objective

Locations

BR (1)