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

Sponsor
Centre Paul Strauss
Study ID
NCT07167134
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Brain Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • D1-3-5 radiotherapy — RADIATION
    23.1 Gray (Gy) delivered in 3 fractions of 7.7 Gy at D1, D3, and D5
  • D1-2-3 radiotherapy — RADIATION
    23.1 Gray (Gy) delivered in 3 fractions of 7.7 Gy at D1, D2, and D3

Study Details

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.

Key Dates

First listed
Sep 11, 2025
Start date
Oct 31, 2025
Status verified
Sep 2025
Primary completion
Oct 31, 2028
Completion
Apr 30, 2030

Study Design

Enrollment
264 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Experimental: 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.

Primary Outcome Measure

Local control of brain metastases at 6 months [ Time Frame: at 6 months ]

Central Contacts

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