Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06243003

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, China

Actively Recruiting

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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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