EUCTR2019-002196-34-IT进行中（未招募）1 期
A Prospective Phase II Single-Arm Trial on Neoadjuvant Peptide Receptor Radionuclide Therapy with 177Lu-DOTATATE Followed by Surgery for resectable Pancreatic Neuroendocrine Tumors (Neo.Lu.Pa.NET) - Neo.Lu.Pa.NET
OSPEDALE SAN RAFFAELE0 个研究点目标入组 30 人开始时间: 2021年6月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •o Age > 18 years
- •o Morphological confirmation by high-quality imaging technique (MR or CT scan)
- •o Cytological or histologically confirmed sporadic resectable nonfunctioning PanNETs (NF-PanNETs) with positive 68Ga-DOTATOC PET/CT (with primary lesion uptake greater than the normal liver and SUV bw max = 15) and at least one of the following high-risk features”:
- •o Radiological tumour size > 40 mm
- •o Well differentiated G2 NF-PanNETs with Ki67 >10% or well differentiated NF-PanNETs G3
- •o Presence of nearby organs involvement
- •o Vascular invasion (excluding the presence of superior mesenteric vein/portal vein invasion > 180° and/or celiac trunk/superior mesenteric artery invasion)
- •o Mesenteric and/or portal and/or splenic vein thrombosis
- •o Presence of a single resectable liver metastasis
- •o Presence of enlarged hypervascularized lymph nodes at imaging that are positive at 68Ga-DOTATOC PET/CT
- •o Absence of extra-abdominal disease
- •o Absence of peritoneal carcinomatosis
- •o Karnofsky Performance Status = 90 or o ECOG-PS=0
- •o ASA <= 3
- •o Preserved hematologic, hepatic and renal parameters (WBC> 2,500/ml [ANC> 1,500/mcl]; Hb> 10g/dL; PTL> 100,000/mcl; bilirubin< 2.5 mg/dl, creatinine< 2 mg/dl);
- •o Absence of serious disease which can compromise safety (cardiac failure, previous myocardial infarction within prior 6 months, history of psychiatric disabilities, synchronous malignancy)
- •o Informed consent
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •o Age < 18 years
- •o Negative functional Imaging (68Ga-DOTATOC PET/CT)
- •o Presence of genetic syndrome (MEN1, VHL, NF)
- •o Functioning PanNET
- •o NF-PanNEC G3
- •o Absence of high-risk features” as defined above
- •o Presence of extra abdominal disease
- •o Presence of multiple liver metastases
- •o Presence of peritoneal carcinomatosis
- •o Previous PanNET-directed treatment
- •o Karnofsky Performance Status < 90% or ECOG-PS > 0
- •o Inadequate bone marrow, liver and kidney function.
- •o Presence of serious disease which can compromise safety (cardiac failure, previous myocardial infarction within prior 6 months, history of psychiatric disabilities, synchronous malignancy)
- •o Bone marrow invasion
- •o Life expectancy less than 6 months
- •o Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- •o Known or suspected non-compliance, drug or alcohol abuse.
- •o Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •o Participation in another study with investigational drug within the 30 days preceding and during the present study or 5 half-life of the experimental drug.
- •o Enrolment of the investigator, his/her family members, employees and other dependent persons
- •o Creatinine clearance < 30 mL/min calculated by the Cockroft Gault method
- •o Uncontrolled congestive heart failure (NYHA III, IV).
- •o Total bilirubin > 3 x normal rate
- •o Serum albumin < 3.0 g/dL u
- •o Hb concentration < 5.0 mmol/L (<8.0 g/dL); WBC < 2x10E9/L (2000/mm3); platelets < 75x10E9/L (75x10E3/mm3)
- •o Pregnancy or lactation
- •o Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant are not allowed to participate in this study UNLESS they are using highly effective methods of highly effective contraception (failure rate <1%/year) throughout the study and for 12 months after the administration of the last cycle of 177Lu-DOTATATE (see par. 8.1)
- •o Potential fertile men with female partner of child-bearing potential, during the study period and for at least 1 cycle of spermatogenesis (90 days) after the administration of the last cycle of 177Lu-DOTATATE (see par. 8.1)
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