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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.
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 NSCLC patients with brain metastasis. In this study, patients will be randomly assigned in a 1:1 ratio to the study group or the control group. Patients in the study group will receive MRI-guided adaptive stereotactic radiotherapy (SRT) (without PTV expansion margin), while patients in the control group will receive CT-guided conventional standard SRT (with PTV expansion margin). After the completion of treatment, patients will be followed up regularly to assess safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study group | Experimental | 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. |
|
| The control group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI-guided adaptive SRT | Radiation | MRI-guided online adaptive SRT (without PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. MRI will be acquired. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation-related brain necrosis incidence rate | "Radiation-related brain necrosis" refers to brain tissue damage that occurs as a result of radiation therapy. It can be detected by brain MRI imaging. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| intracranial progression-free survival rate | The percentage of patients who, after one year of treatment, have not experienced any progression of their intracranial disease. | 1 year |
| Objective response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Liu | Contact | 13661150862 | liuhuisysucc@126.com | |
| DaQuan Wang | Contact | 13661150862 | wangdq@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24048959 | Background | Shaw 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. | |
| 27936894 | Background | Baliga 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. |
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| Conventional SRT | Radiation | Conventional SRT (with PTV expansion margin). The total dose will be 30Gy/5 fractions, administered once daily. CBCT will be acquired. |
|
To evaluate the effectiveness of a treatment for brain tumors based on RECIST 1.1 criteria.
| 1-year |
| Overall survival | The percentage of patients who are alive after one year of treatment. | 1 year |
| Radiation-related Neurotoxicity | "Neurotoxicity" refers to the harmful effects that certain substances or conditions can have on the nervous system, which was examined based on RECIST 1.1 criteria. | 1 year |
| 25322150 | Background | Lagendijk 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. |
| 16980682 | Background | Khoo 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. |
| 27362636 | Background | Stemkens B, Tijssen RH, de Senneville BD, Lagendijk JJ, van den Berg CA. 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. |
| 26531846 | Background | Glitzner 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. |
| 23205789 | Background | Ma 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. |
| 29135471 | Background | Raaymakers BW, Jurgenliemk-Schulz IM, Bol GH, Glitzner M, Kotte ANTJ, van Asselen B, de Boer JCJ, Bluemink JJ, Hackett SL, Moerland MA, Woodings SJ, Wolthaus JWH, van Zijp HM, Philippens MEP, Tijssen R, Kok JGM, de Groot-van Breugel EN, Kiekebosch I, Meijers LTC, Nomden CN, Sikkes GG, Doornaert PAH, Eppinga WSC, Kasperts N, Kerkmeijer LGW, Tersteeg JHA, Brown KJ, Pais B, Woodhead P, Lagendijk JJW. First patients treated with a 1.5 T MRI-Linac: clinical proof of concept of a high-precision, high-field MRI guided radiotherapy treatment. Phys Med Biol. 2017 Nov 14;62(23):L41-L50. doi: 10.1088/1361-6560/aa9517. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001932 | Brain Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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