Status:
TERMINATED
A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET)
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Conditions:
Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This European, prospective, multicentre, double-blind randomised study will evaluate the effect of lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastati...
Detailed Description
This is a European, prospective, multicentre, double-blind randomised study evaluating lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally ad...
Eligibility Criteria
Inclusion
- 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%)
- Progressive before first-line treatment
- 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 biotherapy (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
- Effective contraception for male or female patients of childbearing age, defined as: oral contraceptives, intra-uterine devices, barrier contraceptive methods along with a spermicide gel, or surgical sterilisation. 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT02288377
Start Date
January 1 2015
End Date
January 1 2020
Last Update
January 18 2023
Active Locations (24)
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1
Clinique Universitaire saint-Luc
Brussels, Belgium
2
CHU d'Angers - Hôtel Dieu
Angers, France
3
CHU - Hôpital Avicenne
Bobigny, France
4
CHU Côte de Nacre
Caen, France