The prognosis of extensive-stage small cell lung cancer is still very poor, even for those who received chemotherapy and immunotherapy. This experimental study is a real-world research design to evaluate the effectiveness and safety of prophylactic cranial irradiation in patients with extensive-stage small cell lung cancer who with first-line chemotherapy combined with immunotherapy.
This study is a prospective trial. This study included ES-SCLC patients who response after standard first-line treatment, and aimed to explore the safety and effectiveness of prophylactic cranial irradiation in this treatment modality. The primary endpoint is progression-free survival in the brain.The secondary endpoints includes OS, PFS. The indicators for evaluating safety are the incidence and severity of adverse events.The exploratory endpoint is the molecular biomarkers for efficacy and toxicity predicting from tumor tissue and peripheral blood TMB. The trial was designed by the National Cancer Center/Cancer Hospital of the Chinese Academy of Medical Sciences and Peking Union Medical College. The hypothesis is that preventive brain irradiation is safe and effective in the treatment of extensive SCLC combined with chemotherapy and immunotherapy.
Study Type
OBSERVATIONAL
Enrollment
100
The extensive-stage SCLC patients will receive prophylactic cranial irradiation ±immunotherapy after standard first-line chemotherapy combined with immunotherapy, until disease progression or death
Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGProgression-free survival in the brain
The length of time during and after treatment for a disease in which the patient lives with the disease but the intracranial lesions do not worsen
Time frame: 1 year
Progression-free survival (PFS)
The length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse
Time frame: 1 year
Overall survival (OS)
The time from treatment to death from any cause
Time frame: 1 year
Adverse events
The incidence and severity of adverse events related to treatments
Time frame: 1 year
The cognitive function of the patient
Use the Montreal Cognitive Screening Scale (MoCA) to score, the total score is 30 points, ≥26 points are normal
Time frame: 1 year
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