RecruitingPhase 2NCT03696680
Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal
Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps
Sponsor
Centre Francois Baclesse
Enrollment
46 participants
Start Date
Jan 16, 2019
Study Type
INTERVENTIONAL
Conditions
Summary
This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases
Eligibility
Min Age: 18 Years
Inclusion Criteria24
- 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 Criteria15
- 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
Interventions
RADIATIONFSRT Stereotactic radiation therapy
For each metastasis, dose of 30 Gy in 3 fractions at 10 Gy / fraction over 7 days
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03696680