Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis

Sponsor
University Hospital Ostrava
Study ID
NCT06933199
Status
Recruiting
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Conditions

  • Brain Metastases

Eligibility Criteria

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

Interventions

  • Neoadjuvant Stereotactic Radiotherapy (NaSRT) — RADIATION
    Neoadjuvant Stereotactic Radiotherapy (NaSRT) gives radiotherapy before surgery from many different angles around the body. The beams meet at the tumor. This means the tumor receives a high dose of radiation and the tissues around it receive a much lower dose. This lowers the risk of side effects.
  • Postoperative Stereotactic Radiotherapy (SRT) — RADIATION
    Postoperative Stereotactic Radiotherapy (SRT) gives radiotherapy after surgery from many different angles around the body. The beams meet at the tumor. This means the tumor receives a high dose of radiation and the tissues around it receive a much lower dose. This lowers the risk of side effects.

Study Details

This multicentre proof-of-concept study, involving 4 centers, aims to establish the value of fractionated neoadjuvant stereotactic radiotherapy (NaSRT) as a new treatment paradigm for brain metastases (BM) in the frame of the Czech neurooncology network. Most relevant studies published to date used single-fraction radiotherapy and dealt with the inherent bias related to their retrospective nature. The researchers aim to increase the level of evidence for this treatment paradigm together with other similar ongoing studies.

Key Dates

First listed
Apr 18, 2025
Start date
May 1, 2025
Status verified
May 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
260 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant NaSRT - prospective
    Patients undergoing neoadjuvant NaSRT will be enrolled prospectively in this study arm.
  • Active Comparator: Postoperative SRT - retrospective
    Patients who underwent postoperative SRT in the past will be analyzed retrospectively in this study arm.

Primary Outcome Measure

Acute Toxicity [ Time Frame: 3 months ]

Central Contacts

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