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

ConditionBrain Metastasis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaciej Harat

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

At least one brain metastasis appropriate for resection and not previously treated with SRS.

Lesions ≥2.5 cm and ≤6 cm in largest dimension.

Index lesion(s) will be treated, as outlined in the treatment section of the protocol.

Disqualifiers

No resectable lesion ≥2.5 cm.

Unresectable >4 cm lesion.

Previous whole brain irradiation.

Progressive brain lesion treated with SRS.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neoadjuvant Stereotactic Body Radiation Therapy (SBRT)

    Procedure/Surgery

    Single dose of 12-16 Gy

  • Multi-fraction Stereotactic Body Radiation Therapy (SBRT)

    Procedure/Surgery

    30 Gy treatment in five fractions

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: Neoadjuvant SRS (Arm 1)Experimental treatment 1 intervention
Group B: mfSRS alone (arm 2)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Central nervous system (CNS) composite event (CE)

Number of participants experiencing a central nervous system (CNS) composite event (CE). A CNS CE is defined as the occurrence of at least one of the following events: local recurrence (LR) of a treated lesion, symptomatic radiation necrosis (SRN) of a treated lesion, or development of leptomeningeal disease (LMD). This is a composite endpoint analyzed as a single binary outcome per participant.

Time frame
From date of randomization to the date of a documented LR, SRN, or LMD, whichever comes first, assessed up to 12 months

Secondary outcomes

1

Overall survival (OS)

OS is defined as the time between randomization and death due to any cause. Patients without an event will be censored at the date of last follow-up. Patients with no post-baseline follow-up for progression will be censored at the day of randomization. Median, six-month, and one-year OS will be measured

Time frame
From date of randomization to the date of death or 12 months, whichever comes first
2

Progression-free survival (PFS)

PFS is defined as the time from randomization until radiographic progression, based on Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria (including local recurrence and distant brain metastases), or death from any cause. Patients without an event will be censored at the date of last progression-free follow-up. Patients without post-baseline follow-up will be censored at the date of randomization. Median, 6-month, and 1-year PFS will be reported.

Time frame
From date of randomization to the date of death or 12 months, whichever comes first
3

Incidence of adverse events (any grade)

All treatment-related adverse events (AEs) will be recorded from screening until disease progression or death. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. The number and proportion of participants experiencing at least one adverse event of any grade will be summarized by treatment arm.

Time frame
From date of randomization to the date of death or 12 months, whichever occurs first
4

Incidence of grade ≥3 adverse events

The number and proportion of participants experiencing at least one treatment-related adverse event of grade 3 or higher, as defined by NCI CTCAE version 5.0, will be compared between treatment arms.

Time frame
From date of randomization to the date of death or 12 months, whichever occurs first.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maciej Harat

Lead sponsor

Prof. Franciszek Lukaszczyk Memorial Oncology Center

Sponsor institution

Bydgoszcz University of Science and Technology

Collaborator

Source ClinicalTrials.gov

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