Clinical trial NCT06020066: SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI
Official title: Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Oligo-residual Intracranial Disease After First-line Third-generation EGFR Inhibitors: a Multicenter, Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Brain Metastases
Non-small Cell Lung Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite the impressive response rate to third-generation EGFR-TKIs, resistance inevitably develops in most patients. Stereotactic radiotherapy plays a growing role in the management of patients with brain metastasis. This study aims to evaluate the efficacy and safety of stereotactic radiotherapy for oligo-residual intracranial disease after first-line third-generation EGFR Inhibitors.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed non-small cell lung cancer;
* Clinical stage IV (AJCC, 8th edition, 2017);
* EGFR mutations: EGFR L858R, EGFR exon 19 deletion;
* Age ≥18 years;
* KPS score ≥70;
* Brain metastasis at the time of diagnosis;
* Complete baseline imaging assessment of metastatic lesions, including enhanced MRI for brain;
* Receiving first-line treatment with third-generation EGFR inhibitors;
* After 3-6 months of third-generation EGFR inhibitor treatment, imaging review indicates no progression of extracranial lesions, and brain lesions are evaluated by thin-layer (1mm layer) enhanced MRI, meeting the following criteria:

  * No more than 10 remaining brain lesions;

    * The maximum diameter of the remaining brain lesions does not exceed 3cm;

      * At least one remaining brain lesion has a diameter greater than 5mm;

        * After evaluation by the researcher, all remaining brain lesions are suitable for stereotactic radiotherapy.
* Patient informed consent.

Exclusion Criteria:

* Poor compliance with the study protocol in the investigator's opinion;
* Patients withdrew their informed consent and requested to withdraw from the study;
* Patients were unable to receive regular doses of third-generation EGFR inhibitors due to other underlying conditions, viral side effects, economic factors, etc. (e.g., continuous discontinuation for more than 1 week, cumulative discontinuation for more than 2 weeks).
* Patients did not follow the protocol for follow-up visits as required by this study.

Primary outcomes:
measure: Progression-free survival
timeFrame: Two years
Secondary outcomes:
measure: Overall Survival
timeFrame: Three years
measure: Intracranial progression-free survival
timeFrame: Two years
measure: Health-related quality of life per QLQ-C30
timeFrame: Two years
measure: Health-related quality of life per QLQ-LC13
timeFrame: Two years
measure: Percentage of Participants With Adverse Events
timeFrame: Two years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhengfei Zhu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Chest Hospital
name: Xuwei Cai
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongji Hospital
name: Qian Chu
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan Union Hospital, China
name: Xiaorong Dong
role: PRINCIPAL_INVESTIGATOR
affiliation: Hunan Cancer Hospital
name: Lin Wu
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiangya Hospital of Central South University
name: Rongrong Zhou
role: PRINCIPAL_INVESTIGATOR
affiliation: Hubei Cancer Hospital
name: Guang Han
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Cancer Hospital and Institute
name: Hui Zhu
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangsu Cancer Institute & Hospital
name: Jinjun Ye
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
name: Xiaojia Cui
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
name: Guomei Tai
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Zhiyong Yuan
role: PRINCIPAL_INVESTIGATOR
affiliation: Jilin Provincial Tumor Hospital
name: Dejun XIng
role: PRINCIPAL_INVESTIGATOR
affiliation: Jilin Provincial Tumor Hospital
name: Jichen Ren
role: PRINCIPAL_INVESTIGATOR
affiliation: Fujian Cancer Hospital
name: Jiancheng Li
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital of Ningxia Medical University
name: Yanyang Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Ningbo No.2 Hospital
name: Chuangzhou Rao
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital Of Guizhou Medical University
name: Bing Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanfang Hospital, Southern Medical University
name: Zhongyi Dong
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Jiwei Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Zhenzhou Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Hongqing Zhuang
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanchang University Second Affiliated Hospital
name: Anwen Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Taizhou Hospital Affiliated to Wenzhou Medical University
name: Haihua Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hospital
name: Fang Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Jiangnan University
name: Yong Mao
role: PRINCIPAL_INVESTIGATOR
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