Brain MetastasisPhase 3RENESANSNCT07329634
Evaluation of Neoadjuvant Stereotactic Radiosurgery (SRS) and Multi-fraction SRS Alone for the Treatment of Large Brain Metastases
A Phase 3 study testing Neoadjuvant Stereotactic Body Radiation Therapy (SBRT) and Multi-fraction Stereotactic Body Radiation Therapy (SBRT) in people with Brain Metastasis, run by Maciej Harat.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastasis
- What is being tested?
- Neoadjuvant Stereotactic Body Radiation Therapy (SBRT) and Multi-fraction Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Sep 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Seen by a neurosurgeon or radiation oncologist and judged to be appropriate for participation in this study, including the ability to tolerate Neo-SRS, i.e., the ability to lie flat in a stereotactic head mask.
- Any non-index lesion or lesions for which there is no possible resection must measure ≤4.0 cm in maximal dimension on the contrast MRI or CT brain scan obtained ≤35 days prior to pre-registration. Unresected lesions will be treated with SRS or mfSRS.
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- KPS >60
- MRI confirms 1-10 lesions, one of which one is the index lesion. Each non-index lesion (up to nine) must measure ≤4 cm in maximal extent on contrast MRI and not otherwise require resection.
- Known active or history of invasive primary non-central nervous system (CNS) cancer based on a documented histopathological diagnosis within the past three years.
- Patient can tolerate surgery and SRS.
- History/physical examination within 14 days prior to registration.
- A negative urine or serum pregnancy test (in persons of childbearing potential, defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal for at least 12 consecutive months) within ≤14 days prior to registration.
- Participants who are sexually active must agree to use medically acceptable forms of contraception during treatment during this study to prevent pregnancy.
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.
Who cannot join
- No resectable lesion ≥2.5 cm.
- Unresectable >4 cm lesion.
- Previous whole brain irradiation.
- Progressive brain lesion treated with SRS.
- Previous resection of brain metastases.
- Leptomeningeal disease.
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- Lesion diameter >6.0 cm, or more than 20 lesions in the brain.
- Required emergency decompressive surgery for life-threatening intracranial hypertension (with a preference towards adjuvant SRS/mfSRS protocols).
- Prior diagnosis of malignant brain tumor.
- Pediatric patients (age <18 years), pregnant women, and patients who are unable to give informed consent will be excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the detailed description
The RENESANS trial compares the efficacy and safety of two treatment strategies for large brain metastases: neoadjuvant stereotactic radiosurgery (Neo-SRS) and multi-fraction stereotactic radiosurgery (mfSRS) alone. It is a prospective, two-arm, randomized (1:1), controlled, multicentric phase III trial conducted between September 30, 2025 and September 30, 2033 in multiple radiation oncology units in Poland.
Study participants are patients with cancer and a Karnofsky performance status (KPS) >60 who have at least one brain metastasis appropriate for resection, not previously treated with SRS, and measuring ≥2.5 cm and <6 cm in the largest dimension. The intervention arms are: (i) neoadjuvant SRS (a single dose of 12-16 Gy SRS); and (ii) mfSRS alone (30 Gy delivered in 5 fractions).
The primary outcome is the number of participants developing a central nervous system (CNS) composite event, defined as local recurrence of the treated lesions, symptomatic radiation necrosis of the treated lesions, or development of leptomeningeal disease. Secondary outcomes include overall survival (OS), progression-free survival (PFS), adverse events assessed according to NCI CTCAE version 5.0 criteria, and health-related quality of life (QoL) assessed using the EORTC QLQ-C30 and QLQ-BN20 questionnaires.
- Conditions
- Brain Metastasis
- Being tested
- Neoadjuvant Stereotactic Body Radiation Therapy (SBRT), Multi-fraction Stereotactic Body Radiation Therapy (SBRT)
- Keywords
- Brain metastasis, Stereotactic radiosurgery, Neoadjuvant therapy, Multi-fraction therapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Stereotactic Body Radiation Therapy (SBRT)Procedure or surgery
Single dose of 12-16 Gy
Multi-fraction Stereotactic Body Radiation Therapy (SBRT)Procedure or surgery
30 Gy treatment in five fractions
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant SRS (Arm 1) | Experimental | Neoadjuvant SRS Receives: Procedure: Neoadjuvant Stereotactic Body Radiation Therapy (SBRT) |
| mfSRS alone (arm 2) | Active comparator | mfSRS alone Receives: Procedure: Multi-fraction Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization to the date of a documented LR, SRN, or LMD, whichever comes first, assessed up to 12 months
Secondary outcomes (6)
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
Measured: From date of randomization to the date of death or 12 months, whichever comes first
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.
Measured: From date of randomization to the date of death or 12 months, whichever comes first
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.
Measured: From date of randomization to the date of death or 12 months, whichever occurs first
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.
Measured: From date of randomization to the date of death or 12 months, whichever occurs first.
Health-related quality of life (EORTC QLQ-C30)
Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores will be calculated according to the EORTC scoring manual and reported on a standardized scale from 0 to 100.
Measured: From date of randomization to the date of death or 12 months, whichever occurs first
Brain-specific quality of life (EORTC QLQ-BN20)
Brain cancer-specific quality of life will be assessed using the EORTC Brain Cancer Module (QLQ-BN20). Scores will be calculated according to the EORTC scoring manual and reported on a standardized scale from 0 to 100.
Measured: From date of randomization to the date of death or 12 months, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maciej Harat
- Sponsor type
- University, hospital or other
- Collaborators
- Bydgoszcz University of Science and Technology
- Responsible party
- Sponsor-investigator, Maciej Harat, Prof. Franciszek Lukaszczyk Memorial Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329634
- Sponsor's protocol ID
- RENESANS01
- Acronym
- RENESANS
- Status last verified
- Jan 2026
- First submitted
- 2 Sep 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07329634
- Acronym / sponsor ID
- RENESANS / RENESANS01
- Conditions
- Brain Metastasis
- Keywords
- Brain metastasis, Stereotactic radiosurgery, Neoadjuvant therapy, Multi-fraction therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Maciej HaratUniversity, hospital or other
- Collaborators
- Bydgoszcz University of Science and Technology
- Study start
- Jan 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The RENESANS trial compares the efficacy and safety of two treatment strategies for large brain metastases: neoadjuvant stereotactic radiosurgery (Neo-SRS) and multi-fraction stereotactic radiosurgery (mfSRS) alone. It is a prospective, two-arm, randomized (1:1), controlled, multicentric phase III trial conducted between September 30, 2025 and September 30, 2033 in multiple radiation oncology units in Poland.
Study participants are patients with cancer and a Karnofsky performance status (KPS) >60 who have at least one brain metastasis appropriate for resection, not previously treated with SRS, and measuring ≥2.5 cm and <6 cm in the largest dimension. The intervention arms are: (i) neoadjuvant SRS (a single dose of 12-16 Gy SRS); and (ii) mfSRS alone (30 Gy delivered in 5 fractions).
The primary outcome is the number of participants developing a central nervous system (CNS) composite event, defined as local recurrence of the treated lesions, symptomatic radiation necrosis of the treated lesions, or development of leptomeningeal disease. Secondary outcomes include overall survival (OS), progression-free survival (PFS), adverse events assessed according to NCI CTCAE version 5.0 criteria, and health-related quality of life (QoL) assessed using the EORTC QLQ-C30 and QLQ-BN20 questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant SRS (Arm 1) | Experimental | Procedure: Neoadjuvant Stereotactic Body Radiation Therapy (SBRT)Neoadjuvant SRS |
| mfSRS alone (arm 2) | Active comparator | Procedure: Multi-fraction Stereotactic Body Radiation Therapy (SBRT)mfSRS alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- Seen by a neurosurgeon or radiation oncologist and judged to be appropriate for participation in this study, including the ability to tolerate Neo-SRS, i.e., the ability to lie flat in a stereotactic head mask.
Key exclusion criteria (10 listed)
- No resectable lesion ≥2.5 cm.
- Unresectable >4 cm lesion.
- Previous whole brain irradiation.
- Progressive brain lesion treated with SRS.
- Previous resection of brain metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant Stereotactic Body Radiation Therapy (SBRT)Single dose of 12-16 Gy | Procedure or surgery | Neoadjuvant SRS (Arm 1) |
| Multi-fraction Stereotactic Body Radiation Therapy (SBRT)30 Gy treatment in five fractions | Procedure or surgery | mfSRS alone (arm 2) |
Primary outcome
Central nervous system (CNS) composite event (CE)
Time frame: From date of randomization to the date of a documented LR, SRN, or LMD, whichever comes first, assessed up to 12 months
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.
6 secondary outcomes
Overall survival (OS)
Time frame: From date of randomization to the date of death or 12 months, whichever comes first
Progression-free survival (PFS)
Time frame: From date of randomization to the date of death or 12 months, whichever comes first
Incidence of adverse events (any grade)
Time frame: From date of randomization to the date of death or 12 months, whichever occurs first
Incidence of grade ≥3 adverse events
Time frame: From date of randomization to the date of death or 12 months, whichever occurs first.
Health-related quality of life (EORTC QLQ-C30)
Time frame: From date of randomization to the date of death or 12 months, whichever occurs first
Brain-specific quality of life (EORTC QLQ-BN20)
Time frame: From date of randomization to the date of death or 12 months, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Yes. All IPD collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neoadjuvant Stereotactic Body Radiation Therapy (SBRT) and Multi-fraction Stereotactic Body Radiation Therapy (SBRT) in people with Brain Metastasis, run by Maciej Harat.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maciej Harat, MBChB (+48 52 374 30 82, haratm@co.bydgoszcz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central nervous system (CNS) composite event (CE) (time frame: From date of randomization to the date of a documented LR, SRN, or LMD, whichever comes first, assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.