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

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: Hemorrhagic Brain Metastases
• Intervention / Treatment: Radiation: FSRT Stereotactic radiation therapy

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Julien GEFRELOT, MD; Phone Number: 0231455020; Email: j.geffrelot@baclesse.unicancer.fr
• Study Contact Backup: Name: Dinu STEFAN, MD; Phone Number: 0231455020; Email: d.stefan@baclesse.unicancer.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

1

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)	6 months after end of Stereotactic radiation therapy
Local tumoral response rate defined according to the recommendations of the RECIST criteria	6 months after end of Stereotactic radiation therapy

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse
• Collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation; ANOCEF/IGCNO

Publications and helpful links

General Publications

• Lesueur P, Kao W, Leconte A, Geffrelot J, Lequesne J, Lacroix J, Brachet PE, Hrab I, Royer P, Clarisse B, Stefan D. Stereotactic radiotherapy on brain metastases with recent hemorrhagic signal: STEREO-HBM, a two-step phase 2 trial. BMC Cancer. 2020 Feb 22;20(1):147. doi: 10.1186/s12885-020-6569-1.

Study record dates

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): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: brain metastases; hemorrhagic; FSRT; Stereotactic radiation therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• 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