Clinical trial · Interventional
MR-Linac Guided Adaptive FSRT for Brain Metastases From Non-small Cell Lung Cancer
A Prospective, Phase II Study of MR-Linac Guided Adaptive Fractionated Stereotactic Radiotherapy for Brain Metastases From Non-small Cell Lung Cancer
NCT04946019CI-TRIAL-00083675completedPhase 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 Phase II study is to determine the efficacy and safety of MR-Linac Guided Adaptive fractionated stereotactic radiotherapy (FSRT) in patients with brain metastases in non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Unity-based MR-Linac guided FSRT | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MR-Linac Guided Adaptive FSRT
- description
- Patients will receive FSRT (30Gy in 5 fractions) on the MR-Linac treatment machine.
- interventionNames
- Combination Product: Unity-based MR-Linac guided FSRT
Primary outcomes (1)
- measure
- 1-year intracranial progression-free survival
- timeFrame
- 1 year
Secondary outcomes (8)
- measure
- Objective response rate
- timeFrame
- 2 months
- measure
- 1-year progression-free survival
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 * The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava) * A cavity over 2cm in diameter of primary tumor or metastasis * Bleeding tendency or coagulation disorder * Hemoptysis (1/2 teaspoon blood/day) happened within 1 month * The use of full-dose anticoagulation within the past 1 month * Severe vascular disease occurred within 6 months * Gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months * 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 (16)
- 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
- BACKGROUNDYamamoto M, Serizawa T, Shuto T, Akabane A, Higuchi Y, Kawagishi J, Yamanaka K, Sato Y, Jokura H, Yomo S, Nagano O, Kenai H, Moriki A, Suzuki S, Kida Y, Iwai Y, Hayashi M, Onishi H, Gondo M, Sato M, Akimitsu T, Kubo K, Kikuchi Y, Shibasaki T, Goto T, Takanashi M, Mori Y, Takakura K, Saeki N, Kunieda E, Aoyama H, Momoshima S, Tsuchiya K. Stereotactic radiosurgery for patients with multiple brain metastases (JLGK0901): a multi-institutional prospective observational study. Lancet Oncol. 2014 Apr;15(4):387-95. doi: 10.1016/S1470-2045(14)70061-0. Epub 2014 Mar 10. PMID 24621620
- BACKGROUNDRades D, Janssen S, Dziggel L, Blanck O, Bajrovic A, Veninga T, Schild SE. A matched-pair study comparing whole-brain irradiation alone to radiosurgery or fractionated stereotactic radiotherapy alone in patients irradiated for up to three brain metastases. BMC Cancer. 2017 Jan 6;17(1):30. doi: 10.1186/s12885-016-2989-3. PMID 28061768
- 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
- BACKGROUNDBarrett OC, McDonald AM, Thompson JW, Bredel M, McGwin G, Riley KO, Fiveash JB. Distant brain recurrence in patients with five or more newly diagnosed brain metastases treated with focal stereotactic radiotherapy alone. J Radiosurg SBRT. 2017;4(4):255-263. PMID 28626600
- 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.