Prophylactic Cranial Irradiation in Extensive-stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Real-world Study of Prophylactic Cranial Irradiation After Immunotherapy Combined With Chemotherapy for Extensive-stage Small Cell Lung Cancer

Conditions
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Extensive-stage Small-cell Lung Cancer

Intervention / Treatment
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* Radiation: Prophylactic Cranial Irradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign written informed consent; With extensive small cell lung cancer; Previously received first-line standard chemotherapy, with treatment response of CR or PR; Can tolerate the radiotherapy process; Be over 18 years old Life expectancy ≥ 12 weeks; With the Eastern Cancer Cooperative Group (ECOG) score 0-1 After the systemic treatment was received, there was no brain metastasis on MR before brain preventive irradiation. Exclusion Criteria: Exclude subjects with central nervous system (CNS) metastasis at the first diagnosis; Pregnancy or breastfeeding; Any other conclusive medical, psychiatric and/or social reasons determined by the researcher; Subjects who have previously suffered from other malignant tumors (excluding non-melanoma skin cancer and the following carcinoma in situ: bladder, stomach, colon, endometrial, cervical/dysplasia, melanoma or breast cancer) are not allowed to participate in the study. Unless he/she has been in complete remission at least 2 years before enrolling in the study, and does not need to receive other treatments or does not need to receive other treatments during the study; Researchers believe that the treatment methods used in the study can cause harm or cause basic diseases whose toxicity is difficult to judge when judging adverse events.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| prophylactic cranial irradiation group<br>The extensive-stage SCLC patients will receive prophylactic cranial irradiation after standard first-line chemotherapy combined with immunotherapy, until disease progression or death. | Radiation: Prophylactic Cranial Irradiation<br>* The extensive-stage SCLC patients will receive prophylactic cranial irradiation ±immunotherapy after standard first-line chemotherapy combined with immunotherapy, until disease progression or death<br>* Other names: Immunotherapy;|
| Observation group<br>Patients with extensive-stage SCLC do not receive preventive craniocerebral irradiation after standard first-line chemotherapy combined with immunotherapy until the disease progresses or death. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 
| Overall survival (OS) | The time from treatment to death from any cause | 1 year | 
| Adverse events | The incidence and severity of adverse events related to treatments | 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 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small-cell Lung Cancer, Radiation:prophylactic cranial irradiation