EUCTR2014-003067-38-IT进行中（未招募）1 期
177Lutethium - Peptide Receptor Radionuclide Therapy (Lu-PRRT) plus Capecitabine versus Lu-PRRT in FDG positive, gastro-entero-pancreatic neuroendocrine tumors: a randomized phase II study. (Lu-Ca-S) - Lu-Ca-S
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS0 个研究点目标入组 176 人开始时间: 2018年9月19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
- 176
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
- •1.Histopathologic diagnosis of gastro-entero-pancreatic neuroendocrine tumor, well differentiated G1 – G2 (ki67= 20%) and G3 (ki67= 50%)
- •2.Male or Female, aged >18 years
- •3.Measurable disease according to RECIST 1.1 criteria
- •4.Patients with documented disease will be admitted to therapeutic phase only if the diagnostic receptor imaging, OctreoScan, with a significant uptake in the tumor (grade 2 or 3, according to Rotterdam scale) and/or PET/CT 68Ga-peptide images with a tumor uptake at least equal to liver background
- •5.Patients with documented disease will be admitted to therapeutic phase only if the 18FDG PET/CT is positive with a SUV > 2.5 at least in one documented lesion.
- •6.Non operable advanced disease
- •7.Documented progression after standard therapy such as long acting octreotide or lanreotide (SS-LAR), Everolimus in P-NETs or platinum based therapy in G3 patients.
- •8.Patients have to finish prior standard chemotherapy or therapeutical radiotherapy (less then 25% body surface) at least 6 weeks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 116
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1.Ki67 index > 50%
- •2.FDG PET negative
- •3.Patients treated with chemotherapy and therapeutic radiotherapy within 6 weeks
- •4.More then 25% body surface radiotherapy
- •5.Patients treated with previous radiometabolic therapy with an adsorbed dose to the kidney more than 23 Gy and 1,2 Gy for the bone marrow or as surrogate of dosimetry, a Total Cumulative Activity of >250 mCi of 90Y dotatoc or >800 mCi of 177Lu dotatate
- •6.All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to a grade = 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE)
- •7.Life expectancy minor than 6 months.
- •8.ECOG performance status >2
- •9.Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- •10.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •11.History of allergic reactions attributed to compounds of similar chemical or biologic composition
- •12.Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •13.Known hypersensitivity to Octreotide and/or Lanreotide, and/or somatostatin correlate peptides
- •14.Known hypersensitivity to capecitabine or to any of its components
- •15.Known hypersensitivity to 5 - fluorouracil.
- •16.Other known malignant neoplastic diseases in the patient’s medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix);
研究者
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