Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal (STEREO-HBM)
Primary Purpose
Hemorrhagic Brain Metastases
Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
FSRT Stereotactic radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhagic Brain Metastases focused on measuring hemorrhagic, brain metastases, FSRT, Stereotactic radiation therapy
Eligibility Criteria
Inclusion Criteria:
- Age> 18 years
- Performance Status 0 or 1
- Patient with less than 4 brain metastases [of a solid tumor 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 *
Patient with controlled extra-cranial disease under systemic treatment (chemotherapy or targeted therapy):
- illness in complete response
- partial response or stable illness for more than 3 months
- 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 +
- Patient without concomitant anti-cancer therapy (chemotherapy, hormone therapy, immunotherapy, 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
- 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, melanoma, 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
- Evolutionary extra-cranial disease
- Any associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study
- Participation in a therapeutic trial within 30 days
- Patient deprived of liberty or under guardianship
Sites / Locations
- Centre de la BaieRecruiting
- Centre François BaclesseRecruiting
- Institut de Cancérologie de LorraineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FSRT Stereotactic radiation therapy
Arm Description
Each cerebral metastasis (hemorrhagic or otherwise) will be treated by radiation
Outcomes
Primary Outcome Measures
Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage)
Local tumoral response rate defined according to the recommendations of the RECIST criteria
Secondary Outcome Measures
Full Information
NCT ID
NCT03696680
First Posted
October 3, 2018
Last Updated
June 21, 2022
Sponsor
Centre Francois Baclesse
Collaborators
ANOCEF/IGCNO, Groupement Interrégional de Recherche Clinique et d'Innovation
1. Study Identification
Unique Protocol Identification Number
NCT03696680
Brief Title
Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal
Acronym
STEREO-HBM
Official Title
Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
ANOCEF/IGCNO, Groupement Interrégional de Recherche Clinique et d'Innovation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Brain Metastases
Keywords
hemorrhagic, brain metastases, FSRT, Stereotactic radiation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FSRT Stereotactic radiation therapy
Arm Type
Experimental
Arm Description
Each cerebral metastasis (hemorrhagic or otherwise) will be treated by radiation
Intervention Type
Radiation
Intervention Name(s)
FSRT Stereotactic radiation therapy
Intervention Description
For each metastasis, dose of 30 Gy in 3 fractions at 10 Gy / fraction over 7 days
Primary Outcome Measure Information:
Title
Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage)
Time Frame
6 months after end of Stereotactic radiation therapy
Title
Local tumoral response rate defined according to the recommendations of the RECIST criteria
Time Frame
6 months after end of Stereotactic radiation therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age> 18 years
Performance Status 0 or 1
Patient with less than 4 brain metastases [of a solid tumor 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 *
Patient with controlled extra-cranial disease under systemic treatment (chemotherapy or targeted therapy):
illness in complete response
partial response or stable illness for more than 3 months
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 +
Patient without concomitant anti-cancer therapy (chemotherapy, hormone therapy, immunotherapy, 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
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, melanoma, 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
Evolutionary extra-cranial disease
Any associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study
Participation in a therapeutic trial within 30 days
Patient deprived of liberty or under guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien GEFRELOT, MD
Phone
0231455020
Email
j.geffrelot@baclesse.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Dinu STEFAN, MD
Phone
0231455020
Email
d.stefan@baclesse.unicancer.fr
Facility Information:
Facility Name
Centre de la Baie
City
Avranches
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor PERNIN, MD
Facility Name
Centre François Baclesse
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien GEFFRELOT, MD
Facility Name
Institut de Cancérologie de Lorraine
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selima SELLAMI, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32087691
Citation
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.
Results Reference
derived
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Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal
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