Prophylactic Cranial Irradiation in Extensive-stage Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04947774|
Recruitment Status : Recruiting
First Posted : July 1, 2021
Last Update Posted : September 22, 2021
|Condition or disease||Intervention/treatment|
|Extensive-stage Small-cell Lung Cancer||Radiation: Prophylactic Cranial Irradiation|
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|
|Estimated Enrollment :||100 participants|
|Official Title:||Real-world Study of Prophylactic Cranial Irradiation After Immunotherapy Combined With Chemotherapy for Extensive-stage Small Cell Lung Cancer|
|Actual Study Start Date :||November 1, 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||October 2022|
prophylactic cranial irradiation group
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
The extensive-stage SCLC patients will receive prophylactic cranial irradiation ±immunotherapy after standard first-line chemotherapy combined with immunotherapy, until disease progression or death
Other Name: Immunotherapy
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.
- Progression-free survival in the brain [ Time Frame: 1 year ]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
- Progression-free survival (PFS) [ Time Frame: 1 year ]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
- Overall survival (OS) [ Time Frame: 1 year ]The time from treatment to death from any cause
- Adverse events [ Time Frame: 1 year ]The incidence and severity of adverse events related to treatments
- The cognitive function of the patient [ Time Frame: 1 year ]Use the Montreal Cognitive Screening Scale (MoCA) to score, the total score is 30 points, ≥26 points are normal
- Exploratory end point including biomarkers [ Time Frame: 1 year ]To explore the correlation of PD-L1 expression in tumor tissue , TCR, ctDNA in peripheral blood and efficacy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04947774
|Contact: Liu Wen-Yang, MDfirstname.lastname@example.org|
|Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences||Recruiting|
|Beijing, Beijing, China, 100021|
|Contact: wang Luhua, MD|
|Principal Investigator: Wang Luhua, MD|
|Principal Investigator: Bi Nan, MD|
|Study Director:||Bi Nan, MD||Cancer Hospital, CAMS and PUMC|