EUCTR2007-005517-20-IT进行中（未招募）不适用
Receptor radionuclide therapy with [177Lu-DOTA]0,Tyr3-octreotate (177Lu-DOTATATE): a phase II trial. - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients, male and female, with the following:
- •- Histologic diagnosis of neuroendocrine tumors or any other tumor histotype, documented as sst2-positive (breast, small cell lung cancer, Hodgkin and Non-Hodgkin lymphoma, high-grade glioma), that may benefit from receptor radionuclide therapy and for which there aren?t any other effective treatments.
- •- Conserved hematological, liver and renal parameters, and in particular:
- •- WBC >2500/μl (ANC>1500/μl); Hb>10g/dl; PTL >100.000/μl; Bilirubin <2.5 mg/dl; Creatinin <2 mg/dl;
- •- Age > 18 years;
- •- Patients with documented disease will be admitted to therapeutic phase only if the diagnostic OctreoScan images demonstrate a significant uptake in the tumour. The tumour uptake will be evaluated with a 3-grade scale, where 1 is the liver uptake and 3 the kidney one: only tumour uptakes grade 2 and 3 will be considered for therapy.
- •- Both local relapses and metastases will be treated.
- •- Disease must be measurable by means of conventional imaging (US, CT, RM).
- •- Before treatment anamnestic data will be collected, physical examination will be performed and diagnostic and laboratory data will be examined.
- •- Patients must not receive other treatments (e.g. chemo- or radiotherapy) from one month before to two months after the completion of 177Lu-DOTATATE cycles.
- •- Before the radiopharmaceutical administration, each patient will be informed about the nature, aim and potential risks of the study, and will sign an informed consent (see attached document n.1) before the beginning of therapy. Principal investigator must guarantee that the research will be conducted according to the ?Declaration of Helsinki?, in 1964, revised during the 41st World Medical Assembly, in 1989 in Hong Kong, the 48th (Somerset West, 1996) and the 52nd (Edinburgh, 2000) World Medical Assemblies.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients not corresponding to the above criteria.
- •- Pregnancy/breastfeeding (a pregnancy test not older than 7 days is mandatory).
- •- Assessed bone marrow invasion.
- •- Other concomitant neoplasm (excluding in situ basaliomas and radically treated cervical cancers).
- •- ECOG score higher than 2.
- •- Expectancy of life shorter than 6 months.
研究者
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