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

NCT07167134 | Not Yet Recruiting Phase 3

• 1 other identifier: 2021-014
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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 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

Brain Metastases

Keywords

hypofractionated stereotactic radiotherapy; treatment duration

Outcome Measures

Primary Outcomes (1)

• Local control of brain metastases at 6 months

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

  at 6 months

Secondary Outcomes (13)

• Local control of brain metastases at 12, 18 and 24 months

  at 12, 18 and 24 months

• Cerebral control at 12, 18 and 24 months

  at 12, 18 and 24 months

• Overall survival

  From the date of randomization until the date of death from any cause, loss to follow-up, or 24 months, whichever occurs first

• Progression-free survival

  According to local practices until the date of first documented progression or the date of death from any cause or until 24 months, whichever occurs first

• Patient Quality of life

  Before radiotherapy, then at 3, 6, 12, 18 and 24 months from randomization

Study Arms (2)

D1-3-5 radiotherapy

ACTIVE COMPARATOR

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.

Radiation: D1-3-5 radiotherapy

D1-2-3 radiotherapy

EXPERIMENTAL

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.

Radiation: D1-2-3 radiotherapy

Interventions

D1-3-5 radiotherapy RADIATION

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

D1-3-5 radiotherapy

D1-2-3 radiotherapy RADIATION

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

D1-2-3 radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Paul Strauss: lead

Study Sites (1)

ICANS

Strasbourg, France

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Anne ANTHONY

CONTACT

(0)388252413; promotion-rc@icans.eu

Manon VOEGELIN

CONTACT

(0)3 68 33 95 23; promotion-rc@icans.eu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 11, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

FR (1)