Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06933199
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital Ostrava
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jakub Cvek, Assoc.Prof., MD, Ing, PhD, MBA
Principal Investigator Affiliation University Hospital Ostrava
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Czechia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Metastases
Additional Details

The prospective study will evaluate the efficacy and toxicity of neoadjuvant stereotactic radiotherapy (NaSRT) in patients with brain metastases (BM). Clinical data gathered will include local control (LC), the incidence of leptomeningeal disease (LMD), radiological and clinical signs of radiation necrosis (RN), overall survival, and incidence of metachronous brain metastases. The magnetic resonance imaging (MRI) characteristics of irradiated and subsequently resected BM will be obtained according to the usual protocol and specified time intervals. Clinical monitoring will comprise neurological findings, Karnofsky performance status, and quality of life (FACT-Br/EORTC QLQ-C30 questionnaire and EORTC QLQ-BN20 questionnaire. These questionnaires are designed to measure cancer patients' physical, psychological, and social functions. The questionnaires are composed of multi-item scales and single items). The data obtained from the retrospective control group (estimated for 160 patients) will include the same parameters monitored in the consecutive group of patients who underwent surgery at centers included in our study, with or without adjuvant radiotherapy (RT). Formation of this control group corresponding to the NaSRT group will enable the efficacy and risks of NaSRT to be determined in comparison with established treatment modalities.

Arms & Interventions

Arms

Experimental: Neoadjuvant NaSRT - prospective

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

Active Comparator: Postoperative SRT - retrospective

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

Interventions

Radiation: - Neoadjuvant Stereotactic Radiotherapy (NaSRT)

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.

Radiation: - Postoperative Stereotactic Radiotherapy (SRT)

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University Hospital Ostrava, Ostrava, Moravian-Silesian Region, Czechia

Status

Recruiting

Address

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852

Site Contact

Jiří Hynčica

[email protected]

0042059737 #2587

Masaryk Memorial Cancer Institute, Brno, Czechia

Status

Recruiting

Address

Masaryk Memorial Cancer Institute

Brno, , 65653

Site Contact

Tomáš Kazda, Assoc. Prof., MD, PhD

[email protected]

0042072544 #0509

University Hospital Hradec Králové, Hradec Králové, Czechia

Status

Recruiting

Address

University Hospital Hradec Králové

Hradec Králové, , 50005

Site Contact

Igor Sirák, Assoc. Prof., MD, PhD

[email protected]

00420608100251

University Hospital Olomouc, Olomouc, Czechia

Status

Recruiting

Address

University Hospital Olomouc

Olomouc, , 77900

Site Contact

Martin Doležel, prof., MD, PhD

[email protected]

0042073713 #0111

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