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

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

NCT ID: NCT06582940

Condition: MRI-guided Adaptive Radiotherapy
Non-small Cell Lung Cancer
Brain Metastasis

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Brain Neoplasms

Conditions: Keywords:
MRI-guided radiotherapy
lung cancer
brain metastasis

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: Radiation
Intervention name: MRI-guided adaptive SRT
Description: MRI-guided online adaptive SRT (without PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. MRI will be acquired.
Arm group label: The study group

Intervention type: Radiation
Intervention name: Conventional SRT
Description: Conventional SRT (with PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. CBCT will be acquired.
Arm group label: The control group

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.

Detailed description: 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 NSCLC patients with brain metastasis. In this study, patients will be randomly assigned in a 1:1 ratio to the study group or the control group. Patients in the study group will receive MRI-guided adaptive stereotactic radiotherapy (SRT) (without PTV expansion margin), while patients in the control group will receive CT-guided conventional standard SRT (with PTV expansion margin). After the completion of treatment, patients will be followed up regularly to assess safety and efficacy.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 Exclusion Criteria: - 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Sun yat-sen University Cancer Center

Address:
City: Guangzhou
Zip: 510060
Country: China

Status: Recruiting

Contact:
Last name: Hui Liu, MD

Phone: +86-020-87343031
Email: liuhuisysucc@126.com

Start date: March 1, 2024

Completion date: March 1, 2026

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06582940