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
Qualifiers
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
Treatments tested in this trial
- Silibinin
- Placebo
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov