Status:
NOT_YET_RECRUITING
Evolution of Hypofractionated Stereotactic Irradiation for Radio-Resistant Brain Metastases From D1-3-5 to D1-2-3
Lead Sponsor:
Centre Paul Strauss
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The goal of this prospective, multi-center, randomized double-arm clinical trial is to demonstrate a benefit in term of local control of a shorter spread of hypofractionated stereotactic radiotherapy ...
Detailed Description
Brain metastases (BM), originating from various primary tumors, are associated with decreased progression-free survival, overall survival, and neurological function. Stereotactic radiotherapy offers a...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Patients with one or more unoperated brain metastases (1-5) originating from radioresistant primary locations, including melanoma, kidney, digestive, sarcoma, and prostate \*
- Karnofsky Performance Status (KPS) greater than 50% (Annex 3).
- Absence of major psychiatric conditions in the medical history that may interfere with follow-up, based on the investigator's judgement.
- Proficiency in understanding French.
- Signed informed consent.
- For the ancillary study only: Patients included in the SISMIC study at centers with adequate resources and who have agreed to participate in the optional ancillary study.
- Note: Patients who have had one or more surgery for metastasis removal and also have unresectable metastases are eligible for inclusion. Irradiation of the operating bed will follow the same treatment regimen as existing metastases but will not be considered for the evaluation of local control.
Exclusion
- Pregnant or breastfeeding women
- An unoperated brain metastasis whose maximum diameter is \> 3.5 cm
- Patients deprived of liberty or under guardianship (including curatorship).
- Patients with a history of cerebral radiotherapy.
- Patients with known allergy to gadolinium.
- Contraindication to magnetic resonance imaging (MRI).
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2030
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT07167134
Start Date
October 1 2025
End Date
April 1 2030
Last Update
September 11 2025
Active Locations (1)
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1
ICANS
Strasbourg, France