Actively Recruiting
WBRT With Hippocampal-avoidance Technique Followed by SRT for Extensive-stage SCLC With Baseline Brain Metastases
Led by Fudan University · Updated on 2024-02-07
56
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
WBRT With Hippocampal-avoidance Technique Followed by SRT for Extensive-stage SCLC With Baseline Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 MRI/CT, PET/CT or chest CT plus bone scan, neck and abdomen ultrasound/CT before first-line treatment
- Newly diagnosed extensive-stage small cell lung cancer with brain metastases planned to receive at least 4 cycles of standard platinum-based chemotherapy combined with immunotherapy
- Brain metastases suitable for stereotactic radiotherapy: 10 or fewer metastases, maximum tumor volume under 10 ml, maximum tumor diameter under 3 cm, total tumor volume under 15 ml, no leptomeningeal metastasis
- No history of other malignant tumors
- Male or female of childbearing age agrees to use contraception during the trial
- Life expectancy of 3 months or more
- Able to understand and voluntarily sign informed consent
You will not qualify if you...
- Presence of non-small cell lung cancer components on baseline pathology
- Received any antitumor therapy before diagnosis of extensive-stage small cell lung cancer
- Imaging evidence or symptoms of leptomeningeal metastasis
- Unable to undergo contrast-enhanced MRI
- Severe brain metastases symptoms requiring emergency surgery
- Unable to tolerate or complete radiotherapy immobilization
- Symptomatic interstitial lung disease or active pneumonia
- Need for long-term corticosteroid or immunosuppressive therapy
- Allergic or unable to receive PD-1 or PD-L1 immunotherapy
- Pregnant or breastfeeding women
- Severe autoimmune diseases such as inflammatory bowel disease, rheumatoid arthritis, scleroderma, lupus, or vasculitis
- Any medical or clinical conditions that interfere with study results or increase treatment risk as judged by investigator
- Mental illness, substance abuse, or social problems affecting adherence after physician review
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
Z
zhengfei zhu
CONTACT
X
Xiao Chu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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