WBRT With Hippocampal-avoidance Technique Followed by SRT for Extensive-stage SCLC With Baseline Brain Metastases
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
This study aims to evaluate the safety and efficacy of hippocampal-sparing WBRT combined with SRS as first-line treatment for SCLC patients with brain metastases.
Eligibility criteria
Qualifiers
Eastern Cooperative Oncology Group(ECOG) performance status score 0-2;
Small cell lung cancer confirmed by histopathology or cytology;
Complete baseline imaging data (including brain enhanced MRI/CT, positron emission tomography(PET/CT) or chest enhanced CT+ bone scan + neck and abdomen B ultrasound /CT) should be obtained before first-line treatment;
Patients with initial diagnosis of ES-SCLC with brain metastases who planned to receive at least 4 cycles of standard platinum-based doublet chemotherapy combined with immunotherapy (PD-1 or PD-L1 monoclonal antibody) as first-line treatment, and who met the organ function requirements as judged by the investigator;
Disqualifiers
Patients with non-small cell lung cancer (NSCLC) components on baseline pathological examination;
Patients who had received any antitumor therapy prior to ES-SCLC diagnosis;
Patients with imaging evidence of leptomeningeal metastasis or suspected leptomeningeal metastasis with symptoms and signs;
patients unable to undergo contrast-enhanced MRI;
Trial design
Treatments tested in this trial
- HA-WBRT plus SBRT
Treatment groups
56 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov