SILibinin in NSCLC and BC Patients With Single Brain METastasis (SILMET)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorA.O.U. Città della Salute e della Scienza
About this trial
This study aims to evaluate the efficacy of silibinin in preventing recurrence in the brain after complete resection of a brain metastasis (BM) from non-small-cell lung cancer (NSCLC) or breast cancer (BC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed BM from NSCLC or BC by local pathology
Single BM (maximum diameter of 3 cm) on MRI before surgery
Complete surgical resection (MRI-verified within 14 days prior randomization)
pSTAT3 score in reactive astrocytes of peritumoral tissue confirmed by local or central assessment
Disqualifiers
Absence of expression of STAT3 on the reactive astrocytes of brain metastases
Incomplete surgical resection and/or diameters > 3 centimeters of brain metastasis before surgery
Brain metastases that previously received any type of radiation therapy
Progressive systemic disease requiring a change of the antineoplastic therapy
Trial design
Design model
Parallel
Treatments tested in this trial
Silibinin
Dietary supplementSilibinin 1 g/day taken orally plus standard systemic therapy for NSCLC or BC
Placebo
Other interventionPlacebo 1 g/day taken orally plus standard systemic therapy for NSCLC or BC
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: SilibininExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
intracranial local recurrence
to investigate whether silibinin delay the intracranial local recurrence in comparison to placebo
Time frame
up to 12-24 monthsSecondary outcomes
1
intracranial distant recurrence
to investigate whether silibinin delay or avoid the intracranial distant recurrence in comparison to placebo
Time frame
up to 12-24 months2
Intracranial progression-free survival
intracranial local plus distant recurrence
Time frame
up to 12-24 months3
Overall progression-free survival
intracranial plus systemic PFS
Time frame
up to 12-24 months4
Overall survival
to investigate whether silibinin improve the overall survival in comparison to placebo
Time frame
up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov