Clinical trial · Interventional
Elimination of PTV Margins Based on MRI-guided Adaptive Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Brain Metastasis
NCT06582940CI-TRIAL-00097244recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastasis | — | UNRESOLVED | — |
| MRI-guided Adaptive Radiotherapy | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional SRT | Radiation | — | UNRESOLVED |
| MRI-guided adaptive SRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- The study group
- description
- Patients in the study group will receive MRI-guided adaptive stereotactic radiotherapy (without PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. The MRI-linac is used for the delivery of radiotherapy.
- interventionNames
- Radiation: MRI-guided adaptive SRT
- type
- ACTIVE_COMPARATOR
- label
- The control group
- description
- Patients in the study group will receive conventional standard stereotactic radiotherapy (with PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. The conventional linac is used for the delivery of radiotherapy.
- interventionNames
- Radiation: Conventional SRT
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDShaw MG, Ball DL. Treatment of brain metastases in lung cancer: strategies to avoid/reduce late complications of whole brain radiation therapy. Curr Treat Options Oncol. 2013 Dec;14(4):553-67. doi: 10.1007/s11864-013-0258-0. PMID 24048959
- BACKGROUNDBaliga S, Garg MK, Fox J, Kalnicki S, Lasala PA, Welch MR, Tome WA, Ohri N. Fractionated stereotactic radiation therapy for brain metastases: a systematic review with tumour control probability modelling. Br J Radiol. 2017 Feb;90(1070):20160666. doi: 10.1259/bjr.20160666. Epub 2016 Dec 12. PMID 27936894
- BACKGROUNDLagendijk JJ, Raaymakers BW, Van den Berg CA, Moerland MA, Philippens ME, van Vulpen M. MR guidance in radiotherapy. Phys Med Biol. 2014 Nov 7;59(21):R349-69. doi: 10.1088/0031-9155/59/21/R349. Epub 2014 Oct 16. No abstract available. PMID 25322150
- BACKGROUNDKhoo VS, Joon DL. New developments in MRI for target volume delineation in radiotherapy. Br J Radiol. 2006 Sep;79 Spec No 1:S2-15. doi: 10.1259/bjr/41321492. PMID 16980682
- BACKGROUNDStemkens B, Tijssen RHN, de Senneville BD, Lagendijk JJW, van den Berg CAT. Image-driven, model-based 3D abdominal motion estimation for MR-guided radiotherapy. Phys Med Biol. 2016 Jul 21;61(14):5335-55. doi: 10.1088/0031-9155/61/14/5335. Epub 2016 Jun 30. PMID 27362636
- BACKGROUNDGlitzner M, Crijns SP, de Senneville BD, Kontaxis C, Prins FM, Lagendijk JJ, Raaymakers BW. On-line MR imaging for dose validation of abdominal radiotherapy. Phys Med Biol. 2015 Nov 21;60(22):8869-83. doi: 10.1088/0031-9155/60/22/8869. Epub 2015 Nov 4. PMID 26531846
- BACKGROUNDMa LH, Li G, Zhang HW, Wang ZY, Dang J, Zhang S, Yao L, Zhang XM. Hypofractionated stereotactic radiotherapy with or without whole-brain radiotherapy for patients with newly diagnosed brain metastases from non-small cell lung cancer. J Neurosurg. 2012 Dec;117 Suppl:49-56. doi: 10.3171/2012.7.GKS121071.