Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03696680

Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre de la Baie, Avranches, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FSRT Stereotactic radiation therapy

Radiation

For each metastasis, dose of 30 Gy in 3 fractions at 10 Gy / fraction over 7 days

Primary outcomes

  1. Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage)

    Time frame: 6 months after end of Stereotactic radiation therapy

  2. Local tumoral response rate defined according to the recommendations of the RECIST criteria

    Time frame: 6 months after end of Stereotactic radiation therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Dinu STEFAN, MD

CONTACT

[email protected]

0231455020

Julien GEFRELOT, MD

CONTACT

[email protected]

0231455020

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

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

Registry information

Official study title

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

Acronym: STEREO-HBM

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Oct 5, 2018
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.