MRI-guided radiotherapy for lung cancer with brain metastasis
Elimination of PTV Margins Based on MRI-guided Adaptive Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Brain Metastasis
This study is testing whether a new type of MRI-guided radiotherapy without extra safety margins can be as effective and safe as the traditional CT-guided radiotherapy for patients with lung cancer that has spread to the brain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06582940 on ClinicalTrials.gov |
What this trial studies
This study explores the safety and efficacy of eliminating planning target volume (PTV) margins in MRI-guided adaptive stereotactic radiotherapy for patients with non-small cell lung cancer (NSCLC) and brain metastasis. Participants will be randomly assigned to receive either MRI-guided adaptive stereotactic radiotherapy without PTV expansion or conventional CT-guided stereotactic radiotherapy with PTV expansion. Following treatment, patients will be monitored regularly to evaluate the outcomes and safety of the approaches used.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with confirmed non-small cell lung cancer and 1-10 brain metastases.
Not a fit: Patients with small cell lung carcinoma or those requiring surgical intervention for intracranial metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise and effective treatment for lung cancer patients with brain metastasis, potentially reducing side effects and improving outcomes.
How similar studies have performed: Other studies have shown promise in using MRI-guided approaches for radiotherapy, suggesting potential success for this novel method.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Sun yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Hui Liu
- Email: liuhuisysucc@126.com
- Phone: 13661150862
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.