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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal

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

Stereotactic Radiotherapy for Cerebral Metastases with Recent Hemorrhagic Signal (NCT03696680) is a Phase 2 interventional studying Hemorrhagic Brain Metastases, sponsored by Centre Francois Baclesse. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Hemorrhagic Brain Metastases and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 46 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Patient with small cell lung cancer, germ cell tumors, lymphoma, leukemia and multiple myeloma - Patient with a concomitant neurodegenerative disease ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

RADIATION

FSRT Stereotactic radiation therapy

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

Locations (4)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Centre de la Baie
Avranches, France
Centre François Baclesse
Caen, France
Hospices Civils de Lyon
Lyon, France
Institut de Cancérologie de Lorraine
Nancy, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT03696680), the sponsor (Centre Francois Baclesse), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT03696680 clinical trial studying?

This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT03696680?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT03696680?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT03696680. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT03696680. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.