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Evaluation of Neoadjuvant Stereotactic Radiosurgery (SRS) and Multi-fraction SRS Alone for the Treatment of Large Brain Metastases

NCT07329634 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-01-09

No results posted yet for this study

Summary

The prospective, two-arm, randomized, controlled, multicentric phase III RENESANS trial is designed to compare the efficacy and safety of neoadjuvant stereotactic radiosurgery (Neo-SRS) versus multi-fraction stereotactic radiosurgery (mfSRS) in patients with large brain metastases, with the primary objective of evaluating the incidence of central nervous system composite events.

Conditions

  • Brain Metastasis

Interventions

PROCEDURE

Neoadjuvant Stereotactic Body Radiation Therapy (SBRT)

Single dose of 12-16 Gy

PROCEDURE

Multi-fraction Stereotactic Body Radiation Therapy (SBRT)

30 Gy treatment in five fractions

Sponsors & Collaborators

  • Bydgoszcz University of Science and Technology

    collaborator UNKNOWN

  • Maciej Harat

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2029-09-30
Completion
2032-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07329634 on ClinicalTrials.gov