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

NCT ID: NCT02288377

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-01-31

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

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.

Conditions

Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

lanreotide

In this arm, patients will receive lanreotide 120 mg every 28 days until disease progression

Group Type: EXPERIMENTAL

lanreotide

Intervention Type: DRUG

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

placebo

In this arm, patients will receive placebo every 28 days until disease progression

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

lanreotide

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

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federation Francophone de Cancerologie Digestive

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Come Lepage, Pr

Role: PRINCIPAL_INVESTIGATOR

Federation Francophone de Cancerologie Digestive

Locations

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

Countries

Belgium; France; Germany; United Kingdom

References

Lepage C, Dahan L, Bouarioua N, Toumpanakis C, Legoux JL, Le Malicot K, Guimbaud R, Smith D, Tougeron D, Lievre A, Cadiot G, Di Fiore F, Bouhier-Leporrier K, Hentic O, Faroux R, Pavel M, Borbath I, Valle JW, Rinke A, Scoazec JY, Ducreux M, Walter T. Evaluating lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours. Dig Liver Dis. 2017 May;49(5):568-571. doi: 10.1016/j.dld.2017.02.004. Epub 2017 Mar 11.

Reference Type: BACKGROUND

PMID: 28292641 (View on PubMed)

Guiney DG Jr, Hasegawa P, Davis CE. Homology between clindamycin resistance plasmids in Bacteroides. Plasmid. 1984 May;11(3):268-71. doi: 10.1016/0147-619x(84)90035-0.

Reference Type: RESULT

PMID: 6087395 (View on PubMed)

Lepage C, Phelip JM, Lievre A, Le-Malicot K, Dahan L, Tougeron D, Toumpanakis C, Di-Fiore F, Lombard-Bohas C, Borbath I, Coriat R, Lecomte T, Guimbaud R, Petorin C, Legoux JL, Michel P, Scoazec JY, Smith D, Walter T. Lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours: An international double-blind, placebo-controlled randomised phase II trial - Prodige 31 REMINET: An FFCD study. Eur J Cancer. 2022 Nov;175:31-40. doi: 10.1016/j.ejca.2022.07.033. Epub 2022 Sep 7.

Reference Type: DERIVED

PMID: 36087395 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PRODIGE31

Identifier Type: -

Identifier Source: org_study_id