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New treatment option for Hemorrhagic Brain Metastases
Official title Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal
ClinicalTrials.gov ID: NCT03696680
What this study is testing
- What it's testing
- This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Brain injury (s) measuring between 5 and 30 mm in diameter
- Patient eligible for stereotactic radiotherapy after a decision of the multidisciplinary committee
You likely can't join if
- 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 ...)
See the full eligibility 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...
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Avranches, France
- Caen, France
- Lyon, France
- Nancy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Avranches, France; Caen, France; Lyon, France; Nancy, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.