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Trial Title:
Prospective Double Arm Randomized Trial: WBRT Alone and WBRT Plus Silibinin
NCT ID:
NCT05793489
Condition:
Brain Metastases, Adult
Conditions: Official terms:
Neoplasm Metastasis
Brain Neoplasms
Silybin
Conditions: Keywords:
Brain Metastases
WBRT
Silibinin
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Prospective double arm randomized trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Silibinin
Description:
WBRT will be concomitant to Silibinin. Silibinin at dose of 500 mg must be administrated
twice a day for the first month, after once a day continuously.
Total dose and fractionation of WBRT: 30 Gy in 10 fractions.
Arm group label:
WBRT + Silibinin
Summary:
The occurrence of brain metastases (BMs) is increasing given the availability of a more
accurate radiological imaging such as MRI for detecting also small brain lesions and the
most effective systemic therapy able to control extracranial disease. Although, the new
target therapy and immunotherapy has proven to be effective on brain metastasis too, a
subgroup of patients shows prove themselves unresponsive to medical treatment. A further
subgroup of patients exhibit diffuse brain disease for the presence of multiple brain
lesion (>10 BMs) or leptomeningeal carcinomatosis. Among these patients the most
treatment employed is represented by whole brain RT. Since the 1950s, whole-brain
radiation therapy (WBRT) has been the most widely used treatment for patients with
multiple brain metastases, given its effectiveness in palliation, widespread
availability, and ease to delivery. However, the median overall survival recorded is
restricted to 3 months, on the average. A better understanding of the molecular and
cellular mechanisms underlying brain metastasis might be expected to lead to improvements
in the overall survival rate for these patients. Recent studies have revealed complex
interactions between metastatic cancer cells and their microenvironment in the brain.
Priego et al. describe that brain metastatic cells induce and maintain the co-option of a
pro-metastatic program driven by signal transducer and activator of transcription 3
(STAT3) in a subpopulation of reactive astrocytes surrounding metastatic lesions. In
patients, active STAT3 in reactive astrocytes correlates with reduced survival from
diagnosis of intracranial metastases. Blocking STAT3 signaling in reactive astrocytes
reduces experimental brain metastasis from different primary tumor sources, even at
advanced stages of colonization. Silibinin (or silybin) is a natural polyphenolic
flavonoid isolated from seed extracts of the herb milk thistle (Silybum marianum).
Silibinin has been shown to impair STAT3 activation. Preclinical studies show that
Silibinin has an anticancer effects in vitro and in vivo.
Based on this background, the investigators designed a double arm randomized trial
evaluating the benefit of Silibinin (in the form of marketed supplement) associated to
WBRT respect to WBRT alone.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age >18 years
- Histological or cytological confirmation of solid tumor malignancy
- Clinical indication for whole brain radiotherapy
- Karnofsky performance status (KPS) ≥60
- Written informed consent
Exclusion Criteria:
- Prior WBRT
- KPS < 60
- Diagnosis of Lymphoproliferative disease
- Pregnant women
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCS Humanitas Research Hospital
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Elena Clerici, MD
Phone:
+390282247310
Email:
elena.clerici@humanitas.it
Start date:
March 6, 2023
Completion date:
March 30, 2026
Lead sponsor:
Agency:
Istituto Clinico Humanitas
Agency class:
Other
Source:
Istituto Clinico Humanitas
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05793489
