Elimination of PTV Margins Based on MRI-guided Adaptive Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Brain Metastasis

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study aims to explore the safety and efficacy of eliminating the planning target volume (PTV) margins based on MRI-guided adaptive stereotactic radiotherapy for non-small cell lung cancer (NSCLC) patients with brain metastasis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Aged 18-75 years

• Histologically or cytologically confirmed non-small cell lung cancer

• 1-10 metastases on contrast-enhanced MRI

• Radiotherapy for extracranial lesions is permitted

• Tyrosine kinase inhibitors (TKI) are permitted in patients with progression of

• intracranial metastases during previous TKI therapy

• Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Normal function of organs and bone marrow within 14 days: Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; absolute neutrophil count≥ 500 cells/mm3; creatinine clearance rate(CCR) ≥45 mL/min; Platelet count≥50,000 cells/mm3; international normalized ratio(INR) ≤1.5#Prothrombin Time (PT)≤ 1.5 × ULN

• Informed-consent

Locations
Other Locations
China
Sun yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Hui Liu
liuhuisysucc@126.com
13661150862
Backup
DaQuan Wang
wangdq@sysucc.org.cn
13661150862
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 168
Treatments
Experimental: The study group
Patients in the study group will receive MRI-guided adaptive stereotactic radiotherapy (without PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. The MRI-linac is used for the delivery of radiotherapy.
Active_comparator: The control group
Patients in the study group will receive conventional standard stereotactic radiotherapy (with PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. The conventional linac is used for the delivery of radiotherapy.
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov