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Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03696680
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Francois Baclesse
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hemorrhagic Brain Metastases
Arms & Interventions

Arms

Experimental: FSRT Stereotactic radiation therapy

Each cerebral metastasis (hemorrhagic or otherwise) will be treated by radiation

Interventions

Radiation: - FSRT Stereotactic radiation therapy

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre de la Baie, Avranches, France

Status

Recruiting

Address

Centre de la Baie

Avranches, ,

Site Contact

Victor PERNIN, MD

[email protected]

0231455020

Centre François Baclesse, Caen, France

Status

Recruiting

Address

Centre François Baclesse

Caen, ,

Site Contact

Julien GEFFRELOT, MD

[email protected]

0231455020

Institut de Cancérologie de Lorraine, Nancy, France

Status

Recruiting

Address

Institut de Cancérologie de Lorraine

Nancy, ,

Site Contact

Selima SELLAMI, MD

[email protected]

0231455020