MRI-guided radiotherapy for lung cancer with brain metastasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sun yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Hui Liu
• Email: liuhuisysucc@126.com
• Phone: 13661150862

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.