EUCTR2021-001306-30-FR进行中（未招募）1 期
A prospective randomized phase II study to assess the schemas of retreatment with Lutathera® ([177Lu]Lu-DOTA-TATE) in patients with new progression of intestinal well-differentiated neuroendocrine tumor. - ReLUTH
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 146
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
- •-Age = 18 years,
- •-Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET),
- •-Patient previously treated with 4 cycles of Lutathera® (defined as First PRRT”),
- •-Disease control after First PRRT” = 12 months,
- •-Patient presenting a progression of disease (clinic, biologic and/or radiologic) after a first PRRT,
- •-Decision of retreatment with Lutathera® (defined as Second PRRT”) validated by RENATEN and/or multidisciplinary tumor board and in the scope of the French reimbursement process,
- •-ECOG performance status 0-2,
- •-Life expectancy = 6 months as prognosticated by the physician,
- •-Somatostatin receptor imaging positive imaging (SSTRi+) disease within 4 months prior to randomization: (may be PET imaging (68Ga-based SSTR analogues) or scintigraphy imaging: 111In-pentetreotide or 99mTc-octreotide. At least 90% of lesions must be positive for SSTRi with a significant uptake (>= liver of surrounding tissue),
- •-Measurable disease per RECIST 1.1 (Appendix 1), on CT/MRI scans, defined as at least 1 lesion with = 1 cm in longest diameter, and = 2 radiological tumors lesions in total,
- •-Adequate bone marrow reserve (Hb > 8 g/dl, neutrophils = 1500/mm³ and platelets = 80 000/mm³),
- •-Negative pregnancy test in women of childbearing potential (the ß-HCG dosage must be = 4 days before inclusion). Women who have no reproductive potential are postmenopausal women or women who have had permanent sterilization, eg. tubal occlusion, hysterectomy, bilateral salpingectomy),
- •-Effective contraception in men or women of childbearing or pre-menopausal age and up to a minimum of 6 months following the end of treatment,
- •-Patient´s signed written informed consent,
- •-Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
- •-Affiliation to the French Social Security System.
- •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
- •-Patient who did not respond (no CR, PR or SD) to first PRRT”.
- •-Radiological progression after two cycles of Second PRRT” according to RECIST version 1.1,
- •-Grade 4 hematotoxicity and/or nephrotoxicity during the initial PRRT, or unresolved AEs categorized as Grade 2 or higher (as per Common Terminology Criteria for Adverse Events (CTCAE v5.0) from previous PRRT cycles or any other therapy for NET, excluding alopecia and peripheral neuropathy,
- •-Pancreatic NET,
- •-NeuroEndocrine Carcinoma,
- •-Prior external beam radiation therapy to more than 25% of the bone marrow,
- •-Severe renal (measured Glomerular Filtration Rate (GFR) according to Modification of Diet in Renal Disease (MDRD) < 40 mL/min or nephrotic syndrome) or hepatic insufficiency (Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2.5 x ULN or ALT/AST > 5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.5 x ULN),
- •-Serum albumin < 3.0 g/dL unless prothrombin time is within the normal range,
- •-Uncontrolled diabetes mellitus as defined by a fasting blood glucose above 2 ULN,
- •-Uncontrolled decompensated heart failure, myocardial infarction uncontrolled, stroke, pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months,
- •-Hypertension that cannot be controlled despite medications (= 160/95 mmHg despite optimal medical therapy)
- •-Brain metastases (unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrolment in the study. Patients with a history of brain metastases must have a head CT scan with contrast or MRI to document stable disease prior to enrolment in the study),
- •-Pregnancy or breast feeding,
- •-Substance abuse, medical, psychological, or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results,
- •-Known hypersensitivity to any of the study drugs, study drug classes, or any constituent of the products,
- •-Concomitant participation or participation within the last 30 days in another clinical trial,
- •-History of other solid tumor in 5 years before the inclusion excepted of cancer in situ of the cervix and skin cancer (basal or squamous cell) treated and controlled.
- •-Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.
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