SBRT-LATTICE-PATHY
2026年6月8日 更新者：Heloísa de Andrade Carvalho、University of Sao Paulo General Hospital
Impact of Partial Stereotactic Body Radiotherapy in Hypoxic Segments of Large-volume Unresectable Tumors (SBRT-LATTICE-PATHY) - a Prospective Phase II Study.
To assess the importance of using SBRT-LATTICE-PATHY for the radiotherapy treatment of large tumors that would be considered intractable by currently used standard techniques.
In this present study, the investigators will have the possibility of combining SBRT and LATTICE techniques, incorporating the concept of hypoxic tissue irradiation, which are potential modulators of abscopal and bystander effects, performing partial punctual treatment in the vertex region, without the need for irradiation of the entire tissue volume, further improving safety in relation to possible toxicities.
研究概览
研究类型
介入性
注册 (估计的)
20
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Principal Investigator
- 电话号码：551126616722
- 邮箱：heloisa.carvalho@hc.fm.usp.br
学习地点
-
-
São Paulo
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São Paulo、São Paulo、巴西、05403905
- 招聘中
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - Instituto de Radiologia
-
接触：
- Principal Investigator
- 电话号码：551126616722
- 邮箱：heloisa.carvalho@hc.fm.usp.br
-
副研究员：
- Thiago Brasileiro de Freitas, MD
-
副研究员：
- Silvio Thiago Pereira Vasconcelos, MD
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副研究员：
- Caroline Castilhano Sampaio, Medical physicist
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- age =or> 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status < 2; benign and malignant tumors for which the use of radiotherapy is well established in the literature;
- tumors =or> 340 cm³ or with a largest diameter =or> 7 cm;
- no indication for any other type of treatment due to lack of proven clinical benefit (surgery, chemotherapy, standard radiotherapy, immunotherapy, targeted therapy, etc.);
- Palliative Prognostic Index (PPI) =or< 2;
- metastatic disease in the central nervous system (CNS), if present, controlled (up to 3 metastases, each up to 1 cm);
- up to 5 extracranial distant metastases (nodal or extranodal) =or< 5 cm; signed Informed Consent Form (ICF).
Exclusion Criteria:
- cases in which tumor volume and/or the patient's clinical condition make adequate immobilization/simulation impossible;
- previous local radiotherapy;
- pregnant patients;
- autoimmune diseases;
- genetic instability syndromes;
- ongoing systemic therapy;
- renal insufficiency that prevents the use of iodinated contrast.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：SBRT-LATTICE-PATHY
1 fraction of 24Gy in intratumoral vertices
|
SBRT-LATTICE-PATHY, a single dose of 24Gy in intratumoral vertices located in hypoxic regions.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of local control at 12 months
大体时间：From enrollment to the end of treatment at 12 months
|
Percentage of participants achieving local control, defined as absence of local tumor progression assessed by imaging (CT).
|
From enrollment to the end of treatment at 12 months
|
|
Tumor volume shrinkage at 12 months
大体时间：From enrollment to the end of treatment at 12 months
|
Percentage reduction in gross tumor volume (GTV) measured by CT at 12 months compared to baseline, calculated as [(baseline volume - follow-up volume) / baseline volume] × 100.
|
From enrollment to the end of treatment at 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
12-month overall survival rate
大体时间：12 months overall survival
|
Percentage of participants alive at 12 months after treatment initiation.
Overall survival is defined as the time from enrollment to death from any cause.
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12 months overall survival
|
|
12-month progression-free survival rate
大体时间：12 months Progression Free Survival
|
Percentage of participants alive and without disease progression at 12 months after treatment initiation.
Progression is assessed by CT imaging.
Time is measured from enrollment to the first documented disease progression or death from any cause, whichever occurs first.
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12 months Progression Free Survival
|
|
Rate of acute adverse events assessed by CTCAE v 5.0
大体时间：15 days, 1 month and 3 months after treatment initiation
|
Incidence and severity of acute adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0).
Reported as the percentage of participants experiencing grade ≥1 adverse events.
Assessed at 15 days, 1 month, and 3 months after treatment initiation.
|
15 days, 1 month and 3 months after treatment initiation
|
|
Rate of late adverse events assessed by CTCAE v5.0
大体时间：6, 9 and 12 months after treatment completion
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Incidence and severity of late adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0).
Reported as the percentage of participants experiencing grade ≥1 adverse events.
Assessed at 6, 9, and 12 months after treatment completion.
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6, 9 and 12 months after treatment completion
|
|
Mean EORTC QLC-C30 Global Health Status / Quality of Life Score)
大体时间：Impact in quality of life in 1, 3, 6, 9 and 12 months after treatment completion
|
Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
The Global Health Status/QoL subscale is scored from 0 to 100, where higher scores indicate better quality of life.
Assessed at 1, 3, 6, 9, and 12 months after treatment.
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Impact in quality of life in 1, 3, 6, 9 and 12 months after treatment completion
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Heloisa de Andrade Carvalho, MD, PhD、University of Sao Paulo
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Yan W, Khan MK, Wu X, Simone CB 2nd, Fan J, Gressen E, Zhang X, Limoli CL, Bahig H, Tubin S, Mourad WF. Spatially fractionated radiation therapy: History, present and the future. Clin Transl Radiat Oncol. 2019 Oct 22;20:30-38. doi: 10.1016/j.ctro.2019.10.004. eCollection 2020 Jan. No abstract available.
- Duriseti S, Kavanaugh JA, Szymanski J, Huang Y, Basarabescu F, Chaudhuri A, Henke L, Samson P, Lin A, Robinson C, Spraker MB. LITE SABR M1: A phase I trial of Lattice stereotactic body radiotherapy for large tumors. Radiother Oncol. 2022 Feb;167:317-322. doi: 10.1016/j.radonc.2021.11.023. Epub 2021 Dec 4.
- Korpics MC, Onderdonk BE, Dadey RE, Hara JH, Karapetyan L, Zha Y, Karrison TG, Olson AC, Fleming GF, Weichselbaum RR, Bao R, Chmura SJ, Luke JJ. Partial tumor irradiation plus pembrolizumab in treating large advanced solid tumor metastases. J Clin Invest. 2023 May 15;133(10):e162260. doi: 10.1172/JCI162260.
- Amendola BE, Perez NC, Wu X, Blanco Suarez JM, Lu JJ, Amendola M. Improved outcome of treating locally advanced lung cancer with the use of Lattice Radiotherapy (LRT): A case report. Clin Transl Radiat Oncol. 2018 Jan 12;9:68-71. doi: 10.1016/j.ctro.2018.01.003. eCollection 2018 Feb.
- Ikeda T, Sun L, Tsuruoka N, Ishigaki Y, Yoshitomi Y, Yoshitake Y, Yonekura H. Hypoxia down-regulates sFlt-1 (sVEGFR-1) expression in human microvascular endothelial cells by a mechanism involving mRNA alternative processing. Biochem J. 2011 Jun 1;436(2):399-407. doi: 10.1042/BJ20101490.
- Tubin S, Popper HH, Brcic L. Novel stereotactic body radiation therapy (SBRT)-based partial tumor irradiation targeting hypoxic segment of bulky tumors (SBRT-PATHY): improvement of the radiotherapy outcome by exploiting the bystander and abscopal effects. Radiat Oncol. 2019 Jan 29;14(1):21. doi: 10.1186/s13014-019-1227-y.
- Tubin S, Ahmed MM, Gupta S. Radiation and hypoxia-induced non-targeted effects in normoxic and hypoxic conditions in human lung cancer cells. Int J Radiat Biol. 2018 Mar;94(3):199-211. doi: 10.1080/09553002.2018.1422085. Epub 2018 Jan 12.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月28日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年6月3日
首先提交符合 QC 标准的
2026年6月8日
首次发布 (实际的)
2026年6月12日
研究记录更新
最后更新发布 (实际的)
2026年6月12日
上次提交的符合 QC 标准的更新
2026年6月8日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 86859225.3.0000.0068
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Spreadsheet data (RedCap), ICF
IPD 共享时间框架
06-03-2026 to 12-31-2028
IPD 共享访问标准
Reasearchers will be able to acess the IPD and supporting information.
To have access, they must contact the principal investigator who will share the ICF and Study Protocol.
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.