Prophylactic Cranial Irradiation in Extensive-stage Small Cell Lung Cancer

• Conditions: Extensive-stage Small-cell Lung Cancer
• Interventions: Radiation: Prophylactic Cranial Irradiation

• Registration Number: NCT04947774
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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

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 Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-22
• Primary Completion: 2022-01
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
prophylactic cranial irradiation group	Prophylactic Cranial Irradiation	The extensive-stage SCLC patients will receive prophylactic cranial irradiation after standard first-line chemotherapy combined with immunotherapy, until disease progression or death.

Primary Outcome Measures

Name	Time	Method
Progression-free survival in the brain	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

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	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)	1 year	The time from treatment to death from any cause
Adverse events	1 year	The incidence and severity of adverse events related to treatments
The cognitive function of the patient	1 year	Use the Montreal Cognitive Screening Scale (MoCA) to score, the total score is 30 points, ≥26 points are normal

Trial Locations

Locations (1)

Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China