NCT07645261招募中2 期
Impact of Partial Stereotactic Body Radiotherapy in Hypoxic Segments of Large-volume Unresectable Tumors (SBRT-LATTICE-PATHY) - a Prospective Phase II Study.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究者
Heloísa de Andrade Carvalho
Principal Investigator
University of Sao Paulo General Hospital
研究点 (1)
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