Hemorrhagic Brain Metastases Clinical Trial
— STEREO-HBMOfficial title:
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
| Status | Recruiting |
| Enrollment | 46 |
| Est. completion date | January 2028 |
| Est. primary completion date | June 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre de la Baie | Avranches | |
| France | Centre François Baclesse | Caen | |
| France | Institut de Cancérologie de Lorraine | Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Francois Baclesse | ANOCEF/IGCNO, Groupement Interrégional de Recherche Clinique et d'Innovation |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage) | 6 months after end of Stereotactic radiation therapy | ||
| Primary | Local tumoral response rate defined according to the recommendations of the RECIST criteria | 6 months after end of Stereotactic radiation therapy |