Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal (STEREO-HBM)

February 7, 2025 updated by: Centre Francois Baclesse

Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps

This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Avranches, France
        • Recruiting
        • Centre de la Baie
        • Contact:
          • Victor PERNIN, MD
      • Caen, France
        • Recruiting
        • Centre François Baclesse
        • Contact:
          • Julien GEFFRELOT, MD
      • Lyon, France
      • Nancy, France
        • Recruiting
        • Institut de Cancérologie de Lorraine
        • Contact:
          • Selima SELLAMI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age> 18 years
  • Performance Status 0 or 1
  • Patient with less than 4 brain metastases [of a solid tumor, including melanoma, with a histologically proven diagnosis for the solid tumor; Patients who have had a metastasectomy and 1 to 3 brain metastatic lesions are eligible.
  • Brain injury (s) measuring between 5 and 30 mm in diameter
  • Patient eligible for stereotactic radiotherapy after a decision of the multidisciplinary committee

  • Presence of intra-tumor bleeding signals on at least one brain injury before stereotactic irradiation and defined by :

    • hyperdense lesion on the non-injected CT (treatment scanner) and / or,
    • spontaneously hyperintense lesion on T1 MRI sequences without gadolinium injection and / or,
    • lesion with hypo signal on T2 sequences *
  • Absence of meningeal tumor invasion
  • Absence of brainstem metastasis

  • DS-GPA depending on the histological type (https://brainmetgpa.com/#start):

    • Lung Adecarcinoma: DS-GPA 2 or +
    • Non-adenocarcinoma lung: DS-GPA 2.5 or +
    • Kidney: DS-GPA 2.5 or +
    • Breast: DS-GPA 2.5 or +
    • Digestive cancer: DS-GPA 3 or +
    • Melanoma: DS-GPA 1.5 or +
  • Patient without concomitant anti-cancer therapy (chemotherapy, hormone therapy, anti-angiogenic or other anti-cancer treatments). Treatments should be suspended for at least 7 days before the start of FSRT radiotherapy. The treatment can be resumed 7 days after the end of radiotherapy. It's not mandatory to suspend immunotherapy
  • Life expectancy estimated at over 6 months
  • Patient cooperating sufficiently to perform the treatment with the use of a thermoformed mask
  • Patient whose neuropsychological capacities make it possible to follow the requirements of the protocol
  • Patient affiliated to a social security scheme
  • Patient giving written consent

Exclusion Criteria:

  • Patient with small cell lung cancer, germ cell tumors, lymphoma, leukemia and multiple myeloma
  • Patient with a concomitant neurodegenerative disease
  • Any symptoms not attributable to cerebral metastasis or cancerous pathology and requiring long-term use of corticosteroids (regardless of dose)
  • Contraindication to brain MRI or gadolinium injection
  • Hemorrhagic disorders other than intra-tumor bleeding from brain lesion (s)
  • Radiosensitizing systemic disease (Neurofibromatosis ...)
  • Thrombocytopenia less than 100,000 cells / mm3
  • Anticoagulant treatment, and / or anti-platelet aggregation with curative et prophylaxic dose during FSRT. If treatment can be delayed for at least 5 days before starting FSRT and resumed 2 weeks after completion of FSRT, the patient is eligible.
  • Hemorrhagic metastasis (s) of the brainstem
  • Planning of the treatment on the target metastasis delivering a dose> 5 Gy on other metastases concomitant
  • Patient with prior cerebral stereotactic irradiation
  • History of total brain irradiation
  • Any associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study
  • Participation in a therapeutic trial that could compromise the conduct of study
  • Patient deprived of liberty or under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FSRT Stereotactic radiation therapy
Each cerebral metastasis (hemorrhagic or otherwise) will be treated by radiation
Radiation: FSRT Stereotactic radiation therapy
For each metastasis, dose of 30 Gy in 3 fractions at 10 Gy / fraction over 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage)
Time Frame: 6 months after end of Stereotactic radiation therapy
6 months after end of Stereotactic radiation therapy
Local tumoral response rate defined according to the recommendations of the RECIST criteria
Time Frame: 6 months after end of Stereotactic radiation therapy
6 months after end of Stereotactic radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Collaborators

Groupement Interrégional de Recherche Clinique et d'Innovation
ANOCEF/IGCNO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2019

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

October 3, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 5, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A00926-49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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