NCT06582940RecruitingPhase 2
Elimination of PTV Margins Based on MRI-guided Adaptive Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Brain Metastasis
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 168 (estimated)
- First submitted
- 28 Aug 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Lung cancer
- NCT number
- NCT06582940
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 168
- From 1 Mar 2024 to the primary completion date, 1 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intracranial metastases needed surgical decompression
- Previous radiotherapy or excision for intracranial metastases
- Major surgery within 28 days or minor surgery or needle biopsy within 48 hours
Other illness
- 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)
- Severe uncontrolled disease
- Uncontrollable seizure or psychotic patients without self-control ability
- Other not suitable conditions determined by the investigators
Other
- Small cell carcinoma of lung
- Patients with contraindications for MRI
- Urine protein 3-4+, or 24h urine protein quantitative \>1g
- Women in pregnancy, lactation period
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.