EUCTR2013-004069-14-IE进行中（未招募）1 期
A european, multicentre, phase II/III randomised double-blind, placebo controlled study evaluating lanreotide as maintenance therapy in patients with non-resectable duodeno-pancreatic neuroendocrine tumours after first-line treatment - REMINET
Fédération Francophone de Cancérologie Digestive (FFCD)0 个研究点目标入组 222 人开始时间: 2014年11月6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
- 222
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
- •Metastatic (synchronous or metachronous) or locally advanced, non-resectable, well-differentiated duodeno-pancreatic neuroendocrine tumour, of grade 1 or 2 (WHO 2010 classification; Ki-67 = 20%)
- •First-line treatment started due to (a, b OR c):
- •a. Presence of symptomatic disease and/or hepatic invasion = 50% and/or bone metastasis
- •b. Documented tumour progression before first line therapy
- •c. Disease progression in patients treated by Somatostatin analogues (analogues treatment must be stopped prior to starting the 1st line of therapy:
- •Histologically confirmed (either on primary tumour or metastases)
- •Pathological diagnosis validated by the NET consulting pathologist
- •Documented stable disease or objective response after first-line treatment, within 4 weeks (28 days) prior to randomisation
- •The first-line treatment will consist of either a chemotherapy or targeted therapy (everolimus or sunitinib) as referred to TNCD or ENETS guidelines. Treatment must have been administered for 3 to 6 months for chemotherapy and for 6 months for biotherapy
- •Non-functional tumour or gastrinoma controlled by PPIs
- •Age > or = 18 years
- •WHO 0, 1 or 2
- •Highly effective contraception for male or female patients of childbearing age, defined as: oral contraceptives, intra-uterine devices or surgical sterilisation (vasectomy, tubal ligation). Female patients should use this contraception throughout the treatment period and for 6 months after the last treatment administration. Male patients should use contraception throughout the treatment period and for 3 months after the last treatment administration.
- •Signed informed consent prior to initiation of any study-specific procedures or treatment.
- •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 111
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 111
排除标准
- •History of haematological malignancy or other cancer, except those treated for more than 5 years and considered as cured, carcinoma in situ of the cervix and treated skin cancer (excluding melanoma)
- •Poorly differentiated neuroendocrine carcinoma or NET grade 3 ENETS (Ki-67 > 20%)
- •If primary resected, bone metastasis exclusively
- •Pre-treatment by somatostatin long-acting analogue
- •Total bilirubin = 60 µmol/L
- •Uncontrolled diabetes
- •Contraindication to product used in the study or its components
- •Tumour arising in the context of a genetic disease
- •Pregnancy or lactation
- •Patients unable to undergo medical follow-up due to geographical, social, psychological or legal reasons
- •Concomitant participation in another clinical trial investigating a treatment during the treatment phase and within 30 days prior to the start of the study treatment.
- •Employment of the subject or a close relative (i.e. spouse/partner, child, parent or sibling) by the CRO, the study site.
- •Patients deprived of their liberty by a judicial or administrative decision, patients admitted to a hospital, social institution or who are under a measure of legal protection, patients hospitalized without consent or who are in an emergency situation.
研究者
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