Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Starting soon Phase 3

Evolution of Hypofractionated Stereotactic Irradiation for Radio-Resistant Brain Metastases From D1-3-5 to D1-2-3

NCT07167134 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2025-10
Last updated
2025-09-11

Condition(s) studied

Brain Metastases

Investigational drug(s) / intervention(s)

D1-3-5 radiotherapyD1-2-3 radiotherapy

D1-3-5 radiotherapy: 23.1 Gray (Gy) delivered in 3 fractions of 7.7 Gy at D1, D3, and D5

D1-2-3 radiotherapy: 23.1 Gray (Gy) delivered in 3 fractions of 7.7 Gy at D1, D2, and D3

Study 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 at D1-2-3 vs D1-3-5, in the treatment of "radioresistant" Brain Metastases (BM). This trial aims to recruit patients with 1 to 5 unoperated BM originating from radioresistant primary sites. Patients will be randomly assigned to either the D1-3-5 radiotherapy arm or the D1-2-3 radiotherapy arm. Stereotactic brain irradiation will be administered at a dose of 33 Gy delivered in 3 fractions.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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).

Primary outcome measure(s)

  • Local control of brain metastases at 6 months — at 6 months
    Local control at 6 months per brain metastasis evaluated with magnetic resonance imaging (MRI)

Trial sites (1)

FacilityCityRegionStatus
ICANS Strasbourg France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07167134 on ClinicalTrials.gov ↗ ← All trials in France