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

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ClinicalTrials.gov Identifier: NCT02288377
Recruitment Status : Recruiting
First Posted : November 11, 2014
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

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.

Condition or disease Intervention/treatment Phase
Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours Drug: lanreotide Drug: Placebo Phase 2 Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2024


Arm Intervention/treatment
Experimental: lanreotide
In this arm, patients will receive lanreotide 120 mg every 28 days until disease progression
Drug: lanreotide
Patients will receive lanreotide 120 mg every 28 days until disease progression

Placebo Comparator: placebo
In this arm, patients will receive placebo every 28 days until disease progression
Drug: Placebo



Primary Outcome Measures :
  1. Rate of patients alive and progression free at 6 months [ Time Frame: estimated 6 months after the last patient is randomized ]
    To evaluate the rate of patients alive and progression free at 6 months, assessed by the investigator according to RECIST criteria (version 1.1)


Secondary Outcome Measures :
  1. Rate of patients alive and progression free at 12 months [ Time Frame: estimated 12 months after the last patient is randomized ]
    To evaluate the rate of patients alive and progression free at 12 months, assessed by the investigator according to RECIST criteria (version 1.1)

  2. Safety [ Time Frame: estimated 6 months after the last patient is randomized ]
    Safety: the toxicities will be described using the NCI-CTC AE version 4.0



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288377


Contacts
Contact: Lila GABA +33 3 80 39 34 83 lila.gaba@u-bourgogne.fr

Locations
Belgium
Clinique Universitaire saint-Luc Recruiting
Bruxelles, Belgium
Contact: Ivan BORBATH       ivan.borbath@uclouvain.be   
Principal Investigator: Ivan BORBATH         
France
CHU d'Angers - Hôtel Dieu Recruiting
Angers, France
Contact: François-Xavier CAROLI-BOSC       FXCaroli-Bosc@chu-angers.fr   
Principal Investigator: François-Xavier CAROLI-BOSC         
CHU - Hôpital Avicenne Recruiting
Bobigny, France
Contact: Thomas APARICIO       thomas.aparicio@aphp.fr   
Principal Investigator: Thomas APARICIO         
CHU Côte de Nacre Recruiting
Caen, France
Contact: Karine BOUHIER-LEPORRIER       bouhierleporrier-k@chu-caen.fr   
Principal Investigator: Karine BOUHIER-LEPORRIER         
CHU Estaing Recruiting
Clermont Ferrand, France
Contact: Caroline PETORIN       cpetorin@chu-clermontferrand.fr   
Principal Investigator: Caroline PETORIN         
Hôpital Beaujon Recruiting
Clichy, France
Contact: Olivia HENTIC DHOME       olivia.hentic@bjn.aphp.fr   
Principal Investigator: Olivia HENTIC DHOME         
CHU Le Bocage Service d'HGE Recruiting
Dijon Cedex, France, 21079
Contact: Côme LEPAGE, Pr    + 33 3 80 29 37 50    come.lepage@u-bourgogne.fr   
Principal Investigator: Côme LEPAGE         
CH Les Oudairies Recruiting
La Roche Sur Yon, France
Contact: Roger FAROUX       roger.faroux@chd-vendee.fr   
Principal Investigator: Roger FAROUX         
Hôpital Edouard Herriot Recruiting
Lyon, France
Contact: Thomas WALTER       thomas.walter@chu-lyon.fr   
Principal Investigator: Thomas WALTER         
CHU La Timone Recruiting
Marseille, France
Contact: Laëticia DAHAN       laetitia.dahan@ap-hm.fr   
Principal Investigator: Laëticia DAHAN         
Hôpital de la Source Recruiting
Orléans, France
Contact: Jean-Louis LEGOUX       jean-louis.legoux@chr-orleans.fr   
Principal Investigator: Jean-Louis LEGOUX         
CHU Cochin Recruiting
Paris, France
Contact: Romain CORIAT       romain.coriat@cch.aphp.fr   
Principal Investigator: Romain CORIAT         
Hôpital Haut Lévêque Bat Magellan, Service d'hépato-gastroentérologie Recruiting
Pessac, France
Contact: Denis SMITH       denis.smith@chu-bordeaux.fr   
Principal Investigator: Denis SMITH         
Hôpital de la Milétrie Recruiting
Poitiers, France
Contact: David TOUGERON       david.tougeron@chu-poitiers.fr   
Principal Investigator: David TOUGERON         
Hôpital Robert Debré Recruiting
Reims, France
Contact: Guillaume CADIOT       gcadiot@chu-reims.fr   
Principal Investigator: Guillaume CADIOT         
CHU de Rennes - Hôpital Pontchaillou Recruiting
Rennes, France
Contact: Astrid LIEVRE       astrid.lievre@chu-rennes.fr   
Principal Investigator: Astrid LIEVRE         
CHU Charles Nicolle Recruiting
Rouen, France
Contact: Frédéric DI FIORE       Frederic.Di-Fiore@chu-rouen.fr   
Principal Investigator: Frédéric DI FIORE         
CHU de Saint Etienne Recruiting
Saint Priest En Jarez, France
Contact: Nadia BOUARIOUA       nadiabouarioua@yahoo.fr ; nadia.bouarioua@chu-st-etienne.fr   
Principal Investigator: Nadia BOUARIOUA         
Hôpital Rangueil Recruiting
Toulouse, France
Contact: Rosine GUIMBAUD       guimbaud.r@chu-toulouse.fr   
Principal Investigator: Rosine GUIMBAUD         
Institut Gustave Roussy Recruiting
Villejuif, France
Contact: Michel DUCREUX       ducreux@igr.fr   
Principal Investigator: Michel DUCREUX         
Germany
Charite Campus Virchow Kilikum Recruiting
Berlin, Germany
Contact: Cornelia EBERHARDT       cornelia.eberhardt@charite.de   
Principal Investigator: Marianne PAVEL         
University Hospital Marburg Recruiting
Marburg, Germany
Contact: Dorothée STARK       starkd@staff.uni-marburg.de   
Principal Investigator: Anja RINKE         
United Kingdom
Royal Free Hospital Neuroendocrine Tumour Unit Recruiting
London, United Kingdom
Contact: Liz WOODFORD       ewoodford@nhs.net   
Principal Investigator: Christos TOUMPANAKIS         
Manchester Academic Health Sciences Centre (MAHSC) Recruiting
Manchester, United Kingdom
Contact: Marie WOOLEY       marie.wooley@christie.nhs.uk   
Principal Investigator: Juan W VALLE         
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
Principal Investigator: Come Lepage, Pr Federation Francophone de Cancerologie Digestive

Publications:
Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT02288377     History of Changes
Other Study ID Numbers: PRODIGE31
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

Keywords provided by Federation Francophone de Cancerologie Digestive:
Lanreotide
Duodeno-pancreatic neuroendocrine tumours
Maintenance treatment

Additional relevant MeSH terms:
Neuroendocrine Tumors
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenoma
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs