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

Last updated: August 31, 2024
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasm Metastasis

Brain Tumor

Non-small Cell Lung Cancer

Treatment

MRI-guided adaptive SRT

Conventional SRT

Clinical Study ID

NCT06582940
GASTO-10115
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

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 EvaluationCriteria 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 timesor 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

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 (NewYork class II or above), active cerebrovascular disease or cardiovascular diseaseoccurred 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

Study Design

Total Participants: 168
Treatment Group(s): 2
Primary Treatment: MRI-guided adaptive SRT
Phase: 2
Study Start date:
March 01, 2024
Estimated Completion Date:
March 01, 2026

Study 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.

Connect with a study center

  • Sun yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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