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Trial Title:
SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI
NCT ID:
NCT06020066
Condition:
Brain Metastases
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Brain Neoplasms
Tyrosine Kinase Inhibitors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
EGFR-TK Inhibitor
Description:
Patients will receive EGFR-TKI until confirmed progression or unacceptable toxicity.
Arm group label:
3rd generation EGFR-TKI
Arm group label:
3rd generation EGFR-TKI+SRS
Intervention type:
Radiation
Intervention name:
Stereotactic radiotherapy
Description:
Patients with oligo-residual intracranial disease after treatment with EGFR-TKI will be
treated with SRS of all intracranial lesions. The choice of dose-fractionation regimen is
at the discretion of the treating radiation oncologist.
Arm group label:
3rd generation EGFR-TKI+SRS
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengfei Zhu, MD
Phone:
+8618017312901
Email:
fuscczzf@163.com
Contact backup:
Last name:
Jianjiao Ni, MD
Email:
nijianjiao8@sina.com
Start date:
August 10, 2023
Completion date:
August 10, 2029
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06020066
