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NOT YET RECRUITING
NCT07329634
PHASE3

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

Sponsor: Maciej Harat

View on ClinicalTrials.gov

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.

Official title: Randomized Evaluation of Neoadjuvant Stereotactic Radiosurgery (SRS) and Multi-fraction SRS Alone for the Treatment of Large Brain Metastases: A Polish Multicenter Trial Protocol

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2026-01

Completion Date

2032-09

Last Updated

2026-01-09

Healthy Volunteers

No

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