Clinical trial · Interventional
Evolution of Hypofractionated Stereotactic Irradiation for Radio-Resistant Brain Metastases From D1-3-5 to D1-2-3
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D1-2-3 radiotherapy | Radiation | — | UNRESOLVED |
| D1-3-5 radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- D1-3-5 radiotherapy
- description
- The prescribed total dose will be 23.1 Gy delivered in 3 fractions of 7.7 Gy on days 1, 3, and 5\*\*. The prescription will be based on 70% isodose line, resulting in a total dose of 33 Gy at the isocenter.
- interventionNames
- Radiation: D1-3-5 radiotherapy
- type
- EXPERIMENTAL
- label
- D1-2-3 radiotherapy
- description
- The prescribed dose will be 23.1 Gy at delivered in 3 fractions of 7.7 Gy on days 1, 2, and 3\*. The prescription will be based on 70% isodose line, resulting in a total dose of 33 Gy at the isocenter.
- interventionNames
- Radiation: D1-2-3 radiotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available