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Trial record 1 of 1 for:    stereo hbm | France
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Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal (STEREO-HBM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03696680
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
ANOCEF/IGCNO
Groupement Interrégional de Recherche Clinique et d'Innovation
Information provided by (Responsible Party):
Centre Francois Baclesse

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

Condition or disease Intervention/treatment Phase
Hemorrhagic Brain Metastases Radiation: FSRT Stereotactic radiation therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: FSRT Stereotactic radiation therapy
Each cerebral metastasis (hemorrhagic or otherwise) will be treated by radiation
Radiation: FSRT Stereotactic radiation therapy
For each metastasis, dose of 30 Gy in 3 fractions at 10 Gy / fraction over 7 days




Primary Outcome Measures :
  1. Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage) [ Time Frame: 6 months after end of Stereotactic radiation therapy ]
  2. Local tumoral response rate defined according to the recommendations of the RECIST criteria [ Time Frame: 6 months after end of Stereotactic radiation therapy ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age> 18 years
  • Performance Status 0 or 1
  • Patient with less than 4 brain metastases [of a solid tumor 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 *
  • Patient with controlled extra-cranial disease under systemic treatment (chemotherapy or targeted therapy):

    • illness in complete response
    • partial response or stable illness for more than 3 months
  • Absence of meningeal tumor invasion
  • Absence of brainstem metastasis
  • DS-GPA of 3 or more
  • Patient without concomitant anti-cancer therapy (chemotherapy, hormone therapy, immunotherapy, 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
  • 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, melanoma, 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 with curative dose, and / or anti-platelet aggregation during FSRT. If treatment can be delayed for at least 5 days before starting FSRT and resumed 2 months 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
  • Evolutionary extra-cranial disease
  • Any associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study
  • Participation in a therapeutic trial within 30 days
  • Patient deprived of liberty or under guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696680


Contacts
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Contact: Julien GEFRELOT, MD 0231455020 j.geffrelot@baclesse.unicancer.fr
Contact: Dinu STEFAN, MD 0231455020 d.stefan@baclesse.unicancer.fr

Locations
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France
Centre François Baclesse Recruiting
Caen, France
Contact: Julien GEFFRELOT, MD         
Institut de Cancérologie de Lorraine Recruiting
Nancy, France
Contact: Philippe ROYER, MD         
Sponsors and Collaborators
Centre Francois Baclesse
ANOCEF/IGCNO
Groupement Interrégional de Recherche Clinique et d'Innovation

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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT03696680    
Other Study ID Numbers: 2018-A00926-49
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Francois Baclesse:
hemorrhagic
brain metastases
FSRT
Stereotactic radiation therapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes