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Focal Intraoperative Radiotherapy of Brain Metastases

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ClinicalTrials.gov Identifier: NCT03789149
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Carl Zeiss Meditec AG
Information provided by (Responsible Party):
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 evaluate local control and the control of brain disease in patients with oligometastatic brain disease (up to 4 lesions) submitted to focal IORTto an isolated surgical cavity.


Condition or disease Intervention/treatment Phase
Brain Metastases, Adult Central Nervous System Metastases Radiation: Intraoperative Radiotherapy Phase 2

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 oligometastatic brain disease (up to 4 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Focal Intraoperative Radiotherapy After Resection of Brain Metastases
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: Intraoperative Radiotherapy
Intraoperative Radiotherapy with a mobile device (Intrabeam, Carl Zeiss AG)
Radiation: Intraoperative 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.
Other Name: Intrabeam




Primary Outcome Measures :
  1. Local control (LC) [ Time Frame: 1 year ]
    Rate of local failure in the surgical cavity

  2. Control of Brain Disease (CBD) [ Time Frame: 1 year ]
    Rate of control in the brain outside


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 1 year ]
    Rate of death related to any cause

  2. Frequency of radiation necrosis [ Time Frame: 1 year ]
    Imaging evaluation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789149


Contacts
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Contact: Douglas G Castro, MD 55 11 2189 5000 ext 5104 douglas.castro@accamargo.org.br
Contact: Antonio Cassio A Pellizzon, MD 55 11 2189 5000 ext 5104 acapellizzon@accamargo.org.br

Locations
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Brazil
AC Camargo Cancer Center Recruiting
São Paulo, SP, Brazil, 01509-900
Contact: Douglas G Castro, MD, MSc    55 11 2189 5000 ext 5104    douglas.castro@accamargo.org.br   
Contact: Antônio Cássio A Pellizzon, MD, PhD    55 11 2189 5000 ext 5104    acapellizzon@accamargo.org.br   
Sponsors and Collaborators
AC Camargo Cancer Center
Carl Zeiss Meditec AG
Investigators
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Principal Investigator: Douglas G Castro, MD AC Camargo Cancer Center

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Responsible Party: AC Camargo Cancer Center
ClinicalTrials.gov Identifier: NCT03789149     History of Changes
Other Study ID Numbers: 2315/17
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: 6 months after publication
Access Criteria: Correlated Area Investigators with publishing background and a defined objective

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AC Camargo Cancer Center:
Intraoperative Radiotherapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases