Clinical trial realized in several centers and in several European countries to evaluate a maintenance treatment by lanreotide in patients having neuroendocrine tumors, localized in duodenum or pancreas. Lanreotide will be compared with the placebo, and neither the patients nor the doctors will know the treatment taken by the patients

Phase 1

• Conditions: on-resectable duodeno-pancreatic neuroendocrine tumours after first line treatment; MedDRA version: 19.1Level: PTClassification code 10067517Term: Pancreatic neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004069-14-IE
• Lead Sponsor: Fédération Francophone de Cancérologie Digestive (FFCD)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-06
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

•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

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified