Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

March 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hemorrhagic complication rate (new hemorrhage or increase of hemorrhage)[ Time Frame: 6 months after end of Stereotactic radiation therapy ]

Local tumoral response rate defined according to the recommendations of the RECIST criteria[ Time Frame: 6 months after end of Stereotactic radiation therapy ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal

Official Title ^ICMJE

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

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Radiation: FSRT Stereotactic radiation therapy
For each metastasis, dose of 30 Gy in 3 fractions at 10 Gy / fraction over 7 days

Study Arms

Experimental: FSRT Stereotactic radiation therapy
Each cerebral metastasis (hemorrhagic or otherwise) will be treated by radiation

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2022

Estimated Primary Completion Date

March 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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, 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Centre Francois Baclesse

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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