Evolution of Hypofractionated Stereotactic Irradiation for Radio-Resistant Brain Metastases From D1-3-5 to D1-2-3
NCT ID: NCT07167134
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
264 participants
INTERVENTIONAL
2025-10-31
2030-04-30
Brief Summary
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Detailed Description
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This prospective, multi-center, randomized, double-arm clinical trial aims to recruit patients with 1 to 5 unoperated brain metastases 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 and will be followed for 2 years. Stereotactic brain irradiation will be administered at a dose of 33 Gy delivered in 3 fractions at the isocenter.
The primary endpoint of the study is the assessment of local control at 6 months per brain metastasis. Secondary endpoints include evaluating cerebral control, overall survival, radionecrosis rate, quality of life, neurological function, and treatment-related toxicity.
A more condensed treatment approach may exploit the radiobiological properties of tumors, potentially increasing their sensitivity to radiation while minimizing the opportunity for tumor repopulation. Moreover, reducing treatment duration also has the potential to improve the patient's quality of life by minimizing fatigue towards the end of the irradiation course.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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D1-3-5 radiotherapy
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.
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
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.
D1-2-3 radiotherapy
23.1 Gray (Gy) delivered in 3 fractions of 7.7 Gy at D1, D2, and D3
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Centre Paul Strauss
OTHER
Responsible Party
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Locations
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ICANS
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-014
Identifier Type: -
Identifier Source: org_study_id
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