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Intraoperative Radiotherapy in Patients With Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04847284
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar

Brief Summary:

Intraoperative radiotherapy (IORT) is a new alternative for local radiotherapy with the advantages of dose escalation, reduced overall treatment time, and enhanced patient convenience, however the degree of efficacy is unknown, as well as and which is the most efficient dose.

The objective of this study is to evaluate the efficacy and safety of IORT in patients with surgical excision of brain metastases at a dose of 20 Gy is at least as effective and safe as other forms of radiation therapy in patients with resection of brain metastases.


Condition or disease Intervention/treatment Phase
Brain Metastases Radiation: Intraoperative radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraoperative Radiotherapy in Patients With Brain Metastases
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2024

Arm Intervention/treatment
Experimental: Single arms
To determine the efficiency and safety of IORT with low-energy photons to the cavity after resection of brain metastases
Radiation: Intraoperative radiotherapy
Intraoperative radiotherapy application immediately following resection of brain metastases.




Primary Outcome Measures :
  1. Median local progression free survival (lPFS) [ Time Frame: 6 months from the date of surgery. ]
    Recurrence within a 0.5 cm margin around the resection cavity, assessed by serial MRI scans and response assessment criteria in neuro-oncology (RANO)

  2. Radiation-related acute neurotoxicity [ Time Frame: 3 months from the date of surgery. ]

    Neurotoxicity related to radiotherapy evaluated according to the scale of the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Score from 0 to 5, with 5 being the worst toxicity

    - Acute toxicity: cerebral edema


  3. Radiation-related late neurotoxicity [ Time Frame: 6 months from the date of surgery. ]

    Neurotoxicity related to radiotherapy evaluated according to the scale of the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Score from 0 to 5, with 5 being the worst toxicity

    - Late toxicity: radionecrosis.



Secondary Outcome Measures :
  1. Median regional PFS (rPFS) [ Time Frame: 6 months from the date of surgery ]
    To any progression outside of the 0.5 cm margin around the resection cavity, assessed by serial MRI scans and RANO response assessment in neuro-oncology .

  2. Global PFS (gPFS) [ Time Frame: 6 months from the date of surgery ]
    The time (in months) from surgery to any intra- and extracranial tumor progress

  3. Median overall survival (OS) [ Time Frame: 6 months from the date of surgery ]
    The time (in months) from surgery of brain metastases to death from by any cause.



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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
  • Karnofsky Performance Status ≥ 70
  • Newly diagnosed cerebral or cerebellar lesion (contrast enhancing on a T1-weighted MRI scan) amenable to total resection with no dural attachment
  • Frozen section confirming a metastasis of an extracranial (i.e. non-CNS) tumor
  • Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy)
  • Adequate birth control

Exclusion Criteria:

  • Leptomeningeal spread and dural attachment (assessed pre- and intraoperatively)
  • Frozen section reveals primary CNS tumor, lymphoma, SCLC (Small-cell lung cancer) or germinoma
  • More than one brain metastasis
  • Psychiatric or social condition potentially interfering with compliance
  • Contraindication against anesthesia, surgery, MRI and/or contrast agents
  • Pregnant or breast-feeding women

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): NCT04847284


Locations
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Spain
Palmira Foro Arnalot Recruiting
Barcelona, Spain, 08003
Contact: Palmira Foro Arnalot, MD, PhD    93248357    pforo@parcdesalutmar.cat   
Principal Investigator: Palmira Foro Arnalot, MD, PhD         
Principal Investigator: Gloria Villalba, MD, PhD         
Sponsors and Collaborators
Parc de Salut Mar
Publications of Results:
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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT04847284    
Other Study ID Numbers: 2020/9548/I
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Parc de Salut Mar:
Brain metastases
Intraoperative radiotherapy
Intrabeam
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