NCT06933199

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started May 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
May 2025Dec 2028

First Submitted

Initial submission to the registry

April 3, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 4, 2025

Status Verified

May 1, 2025

Enrollment Period

3.7 years

First QC Date

April 3, 2025

Last Update Submit

May 1, 2025

Conditions

Brain Metastases

Keywords

Brain MetastasesNeoadjuvant Stereotactic RadiotherapyLeptomeningeal DiseaseQuality of LifeOverall SurvivalAcute Toxicity

Outcome Measures

Primary Outcomes (3)

  • Acute Toxicity

    Acute Toxicity will be assessed in the study subjects according to Common Terminology Criteria for Adverse Events (CTCAE) ver. 5 to 10%.

    3 months

  • Quality of Life Questionnaire (FACT-Br/EORTC QLQ-C30)

    Quality of Life will be assessed in the study subjects using the FACT-Br/EORTC QLQ-C30 questionnaire.

    3 months

  • Quality of Life Questionnaire (EORTC QLQ-BN20)

    Quality of Life will be assessed in the study subjects using the EORTC QLQ-BN20 questionnaire.

    3 months

Secondary Outcomes (5)

  • Time from NaSRT to local progression

    3 years

  • Time from NaSRT to detection of LMD

    3 years

  • Time from NaSRT to the onset of RN

    3 years

  • Time from NaSRT to detection of distant parenchymal metastasis

    3 years

  • Overall Survival

    3 years

Study Arms (2)

Neoadjuvant NaSRT - prospective

EXPERIMENTAL

Patients undergoing neoadjuvant NaSRT will be enrolled prospectively in this study arm.

Radiation: Neoadjuvant Stereotactic Radiotherapy (NaSRT)

Postoperative SRT - retrospective

ACTIVE COMPARATOR

Patients who underwent postoperative SRT in the past will be analyzed retrospectively in this study arm.

Radiation: Postoperative Stereotactic Radiotherapy (SRT)

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.

Neoadjuvant NaSRT - prospective
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.

Postoperative SRT - retrospective

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Karnofsky Performance Status ≥ 60
  • Histologically verified primary cancer disease
  • MRI findings indicating BM
  • Target BM indicated for surgical resection and any other metastases suitable for radical SRT.
  • Target BM between 1 cm and 7 cm at the longest diameter on T1 post-contrast MR imaging

You may not qualify if:

  • Confirmed hematological malignity
  • Small-cell (lung) carcinoma
  • Peracute condition requiring immediate neurosurgical intervention
  • History of whole-brain radiotherapy (WBRT)
  • History of stereotactic radiotherapy to a target brain metastasis
  • Pregnancy
  • Inability to perform surgical resection of the target BM within 7 days after NaSRT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

Masaryk Memorial Cancer Institute

Brno, 65653, Czechia

RECRUITING

University Hospital Hradec Králové

Hradec Králové, 50005, Czechia

RECRUITING

University Hospital Olomouc

Olomouc, 77900, Czechia

RECRUITING

Related Publications (5)

  • DeAngelis LM, Delattre JY, Posner JB. Radiation-induced dementia in patients cured of brain metastases. Neurology. 1989 Jun;39(6):789-96. doi: 10.1212/wnl.39.6.789.

    PMID: 2725874BACKGROUND

  • CHAO JH, PHILLIPS R, NICKSON JJ. Roentgen-ray therapy of cerebral metastases. Cancer. 1954 Jul;7(4):682-9. doi: 10.1002/1097-0142(195407)7:43.0.co;2-s. No abstract available.

    PMID: 13172684BACKGROUND

  • Gavrilovic IT, Posner JB. Brain metastases: epidemiology and pathophysiology. J Neurooncol. 2005 Oct;75(1):5-14. doi: 10.1007/s11060-004-8093-6.

    PMID: 16215811BACKGROUND

  • Barnholtz-Sloan JS, Sloan AE, Davis FG, Vigneau FD, Lai P, Sawaya RE. Incidence proportions of brain metastases in patients diagnosed (1973 to 2001) in the Metropolitan Detroit Cancer Surveillance System. J Clin Oncol. 2004 Jul 15;22(14):2865-72. doi: 10.1200/JCO.2004.12.149.

    PMID: 15254054BACKGROUND

  • Linskey ME, Andrews DW, Asher AL, Burri SH, Kondziolka D, Robinson PD, Ammirati M, Cobbs CS, Gaspar LE, Loeffler JS, McDermott M, Mehta MP, Mikkelsen T, Olson JJ, Paleologos NA, Patchell RA, Ryken TC, Kalkanis SN. The role of stereotactic radiosurgery in the management of patients with newly diagnosed brain metastases: a systematic review and evidence-based clinical practice guideline. J Neurooncol. 2010 Jan;96(1):45-68. doi: 10.1007/s11060-009-0073-4. Epub 2009 Dec 4.

    PMID: 19960227BACKGROUND

MeSH Terms

Conditions

Brain NeoplasmsMeningeal Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jakub Cvek, Assoc.Prof., MD, Ing, PhD, MBA

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737jiri.hyncica@fno.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No masking will be used in the study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will include two groups of study subjects, enrolled prospectively and analysed retrospectively
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2025

First Posted

April 18, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Locations

CZ(4)