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Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis

ConditionBrain Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Ostrava

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Karnofsky Performance Status ≥ 60

Histologically verified primary cancer disease

MRI findings indicating BM

Disqualifiers

Confirmed hematological malignity

Small-cell (lung) carcinoma

Peracute condition requiring immediate neurosurgical intervention

History of whole-brain radiotherapy (WBRT)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Neoadjuvant NaSRT - prospectiveExperimental treatment 1 intervention
Group B: Postoperative SRT - retrospectiveActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Acute Toxicity

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

Time frame
3 months
2

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.

Time frame
3 months
3

Quality of Life Questionnaire (EORTC QLQ-BN20)

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

Time frame
3 months

Secondary outcomes

1

Time from NaSRT to local progression

Time from NaSRT to local progression will be assessed.

Time frame
3 years
2

Time from NaSRT to detection of LMD

Time from NaSRT to detection of LMD will be assessed.

Time frame
3 years
3

Time from NaSRT to the onset of RN

Time from NaSRT to the onset of RN will be assessed.

Time frame
3 years
4

Time from NaSRT to detection of distant parenchymal metastasis

Time from NaSRT to detection of distant parenchymal metastasis will be assessed.

Time frame
3 years

Other outcomes

Sponsors and contacts

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

University Hospital Ostrava

Lead sponsor

University Hospital Olomouc

Collaborator

Masaryk Memorial Cancer Institute

Collaborator

University Hospital Hradec Kralove

Collaborator

Source ClinicalTrials.gov
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