跳至主要内容
临床试验/NCT03543696
NCT03543696已完成不适用

Phase II Clinical Study to Ablate Oligometastatic Deposits by Single Dose Radiotherapy (SDRT) and Metabolic Assessment of Outcome

Fundacao Champalimaud2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
Efficacy of SDRT ablation

研究概览

简要总结

This study focuses on treatment outcomes of human metastatic cancer which usually fares with dismal (<5%) survival at 5 years following first diagnosis of a metastasis. However, a subgroup of patients with an initial oligometastatic presentation (i.e. 1-5 clinically detectable lesions) have been reported to respond to complete surgical removal of detectable deposits with up to 20% disease-free survival at 10 years. Patients relapsing with a second oligometastatic presentation respond to a second round of ablation with encouraging rates of 5-year disease free survival. Based on patterns of response to therapy and relapse, we propose investigate on the hypothesis that metastatic disease may be limited in extent, slowly growing and amenable to successive eradication of metastatic deposits. For visible tumor ablation, we propose to employ the effective and safe technique of Single Dose Image-Guided Radiotherapy (SDRT) and to optimize its use in conjunction with systemic therapy. Where SDRT at a full ablative dose (24Gy) is deemed unfeasible, hypofractionated SBRT (9Gy x3) will be offered. Response assessment will be via local control, poly-metastasis-free survival and overall survival rates. Preliminary phase I/II studies indicate remarkable benefits from the SDRT/SBRT in patients with limited metastatic disease. The expected outcomes may be significant conceptual and practical changes in the management of selected metastatic settings resulting in long-term periods of disease-free and overall survival in settings presently associated with dismal prognosis.

详细描述

This phase II clinical trial is designed assess clinical outcomes following ablation by Single Dose Image Guided Radiotherapy (SDRT) in patients with oligometastatic (OM) presentation (1-5 clinically detectable lesions). For local tumor ablation the investigators will use the novel non-invasive and highly effective technique of SDRT which is capable of conferring long-term local relapse-free rates in approximately 90% of metastatic lesions independently of tumour histology. Historical series with various tumor histologies have shown subgroups of patients with an initial oligometastatic presentation respond to complete surgical removal of detectable deposits, yielding up to 20% disease-free survival at 10 years. The study will determine response rates by metabolic criteria (i.e. PERCIST). Pre- and post-treatment assessment are performed by FDG (or other appropriate PET tracer) PET/CT scans with acquisition of information on lesion(s) location, volume and metabolic parameters. Changes in metabolic avidity post treatment can be used to evaluate the rates of complete metabolic response, stable disease and progression at the site(s) of SDRT to measure local relapse-free survival intervals (LRFS and the kinetics of tracer uptake may serve as a potential predictive tool of treatment response). Additionally, whole-body PET/CT scans can be used to assess distant metastasis-free progression, polymetatstasis-free survival (PMFS). Lesions which are not amenable to the SDRT approach due to the inability to safely fulfill dose/volume constraints, are consistently treated with a hypofractionated approach of three sessions of 9Gy, an established and safe treatment regimen. Comparisons in LRFS, persistence of the oligometastatic status, distant metastasis free-survival, poly-metastasis-free survival, interval between repeat treatments and overall survival will be evaluated evaluated. The impact of systemic treatment, as per current established clinical practices, will also be assessed.

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

入选标准

  • Histologic confirmation of malignancy;
  • FDG PET/CT (or other tracer) PET/CT evidence of limited (1-5) metastases;
  • All detectable lesions must be considered amenable to SDRT or hypofractionated ablation;
  • Age ≥ 18 years;
  • Life expectancy > 6 months;
  • EGOG Performance Status 0-2;
  • Signed informed consent form for treatment;

排除标准

  • Overt poly-metastatic disease (≥5 lesions) as shown by PET/CT scanning;
  • Performance status >2;
  • Severe, active co-morbidity;
  • Significant psychiatric illness;

结局指标

主要结局

Efficacy of SDRT ablation

时间窗: 24 months

Efficacy of Single Dose Radiotherapy (SDRT 24Gy) of metastatic lesions measured by PERCIST criteria with repeated PET-CT studies.

次要结局

  • Progression-free survival(24 months)

研究者

发起方
Fundacao Champalimaud
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Greco, MD

Principal Investigator

Fundacao Champalimaud

研究点 (2)

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