RecruitingPhase 2NCT06582940
Elimination of PTV Margins Based on MRI-guided Adaptive Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Brain Metastasis
Sponsor
Sun Yat-sen University
Enrollment
168 participants
Start Date
Mar 1, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria10
- Aged 18-75 years
- Histologically or cytologically confirmed non-small cell lung cancer
- 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
Exclusion Criteria12
- Small cell carcinoma of lung
- Intracranial metastases needed surgical decompression
- Patients with contraindications for MRI
- Previous radiotherapy or excision for intracranial metastases
- Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months
- Uncontrolled hypertension (systolic \> 150mmHg and/or diastolic \> 100mmHg)
- Major surgery within 28 days or minor surgery or needle biopsy within 48 hours
- Urine protein 3-4+, or 24h urine protein quantitative \>1g
- Severe uncontrolled disease
- Uncontrollable seizure or psychotic patients without self-control ability
- Women in pregnancy, lactation period
- Other not suitable conditions determined by the investigators
Interventions
RADIATIONMRI-guided adaptive SRT
MRI-guided online adaptive SRT (without PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. MRI will be acquired.
RADIATIONConventional SRT
Conventional SRT (with PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. CBCT will be acquired.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06582940
Related Trials
An Observational Study to Assess the Effectiveness and Safety of a Cemiplimab in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe
NCT0536331949 locations
Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
NCT07195695192 locations
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
NCT0711504311 locations
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
NCT06712316184 locations
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
NCT06345729212 locations