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A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET)

Status

Terminated

Phase

Phase 2 / Phase 3

Enrollment

53

Locations

24

Results

Posted

Publications

3

Study summary

What the protocol is testing.

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 metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours.

Full 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 advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours. Depending on the phase II results, the study may be continued into phase III. The treatment and follow-up of patients will be the same in phase II and phase III. After the first-line treatment, patients will be randomly assigned with a 1:1 ratio to receive either lanreotide or placebo. The study treatment should be initiated within 6 weeks following the confirmation date of stable disease or objective response. Treatment period: For each patient, the investigational products (lanreotide or placebo) will be provided according to a double-blind procedure until disease progression or toxicity, in accordance with the protocol. The estimated average treatment duration for all patients is 12 months. Follow-up period: To evaluate overall survival, patients in phase II will have a minimum follow-up period of 12 months; if the study continues to phase III, these patients will have a maximum follow-up period of 10 years. Phase III patients will have a minimum follow-up period of 5 years.

Interventions

Treatment arms and agents.

DRUG

lanreotide

Patients will receive lanreotide 120 mg every 28 days until disease progression

DRUG

Placebo

Timeline

From registration to results.

  1. First posted

    Nov 11, 2014

  2. Study start

    Jan 2015

  3. Primary completion

    Jan 2020

  4. Study completion

    Jan 2020

  5. Results posted

    Oct 4, 2021

  6. Registry updated

    Jan 18, 2023

Outcomes

What the study measures.

Primary outcomes

Proportion of Patients Alive and Progression-free at 6 Months

Time frame · 6 months

The primary endpoint for this phase II study was the proportion of pts alive and progression-free at 6 months after randomisation, evaluated according to the results of the imaging assessment done by the investigator in line with RECIST 1.1 criteria.

Secondary outcomes

Progression-Free Survival

Time frame · up to 2 years

The progression-free survival is the time from inclusion to the first radiological progression or death (all causes). For patients alive without progression date of last news will be considered. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed durin the study (NADIR), or a measurable increase in a nontarget lesion, or the appearance of new lesions

Overall Survival

Time frame · 2 years after the end of the treatment

Overall survival considered all deaths, and time was calculated from randomisation to death.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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%) * 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 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.

Study locations

24 registered sites.

Belgium · France · Germany · United Kingdom. Showing up to 24 locations stored in the fast local snapshot.

Clinique Universitaire saint-Luc

Brussels, Belgium

CHU d'Angers - Hôtel Dieu

Angers, France

CHU - Hôpital Avicenne

Bobigny, France

CHU Côte de Nacre

Caen, France

CHU Estaing

Clermont-Ferrand, France

Hôpital Beaujon

Clichy, France

CHU Le Bocage Service d'HGE

Dijon, France

CH Les Oudairies

La Roche-sur-Yon, France

Hôpital Edouard Herriot

Lyon, France

CHU La Timone

Marseille, France

Hôpital de la Source

Orléans, France

CHU Cochin

Paris, France

Hôpital Haut Lévêque Bat Magellan, Service d'hépato-gastroentérologie

Pessac, France

Hôpital de la Milétrie

Poitiers, France

Hôpital Robert Debré

Reims, France

CHU de Rennes - Hôpital Pontchaillou

Rennes, France

CHU Charles Nicolle

Rouen, France

CHU de Saint Etienne

Saint-Priest-en-Jarez, France

Hôpital Rangueil

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Charite Campus Virchow Kilikum

Berlin, Germany

University Hospital Marburg

Marburg, Germany

Royal Free Hospital Neuroendocrine Tumour Unit

London, United Kingdom

Manchester Academic Health Sciences Centre (MAHSC)

Manchester, United Kingdom

Related trials

More studies on Lanreotide.

Related PeptideStat pages

Put the record in context.

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