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

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
lanreotide
Placebo
Sponsored by
Federation Francophone de Cancerologie Digestive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours focused on measuring Lanreotide, Duodeno-pancreatic neuroendocrine tumours, Maintenance treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinique Universitaire saint-Luc
  • CHU d'Angers - Hôtel Dieu
  • CHU - Hôpital Avicenne
  • CHU Côte de Nacre
  • CHU Estaing
  • Hôpital Beaujon
  • CHU Le Bocage Service d'HGE
  • CH Les Oudairies
  • Hôpital Edouard Herriot
  • CHU La Timone
  • Hôpital de la Source
  • CHU Cochin
  • Hôpital Haut Lévêque Bat Magellan, Service d'hépato-gastroentérologie
  • Hôpital de la Milétrie
  • Hôpital Robert Debré
  • CHU de Rennes - Hôpital Pontchaillou
  • CHU Charles Nicolle
  • CHU de Saint Etienne
  • Hôpital Rangueil
  • Institut Gustave Roussy
  • Charite Campus Virchow Kilikum
  • University Hospital Marburg
  • Royal Free Hospital Neuroendocrine Tumour Unit
  • Manchester Academic Health Sciences Centre (MAHSC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

lanreotide

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of Patients Alive and Progression-free at 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 Outcome Measures

Progression-Free Survival
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
Overall survival considered all deaths, and time was calculated from randomisation to death.

Full Information

First Posted
September 23, 2014
Last Updated
December 21, 2022
Sponsor
Federation Francophone de Cancerologie Digestive
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1. Study Identification

Unique Protocol Identification Number
NCT02288377
Brief Title
A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET)
Acronym
REMINET
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Because of slow recruitment
Study Start Date
January 2015 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federation Francophone de Cancerologie Digestive

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours
Keywords
Lanreotide, Duodeno-pancreatic neuroendocrine tumours, Maintenance treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lanreotide
Arm Type
Experimental
Arm Description
In this arm, patients will receive lanreotide 120 mg every 28 days until disease progression
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
In this arm, patients will receive placebo every 28 days until disease progression
Intervention Type
Drug
Intervention Name(s)
lanreotide
Intervention Description
Patients will receive lanreotide 120 mg every 28 days until disease progression
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Proportion of Patients Alive and Progression-free at 6 Months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival
Description
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
Time Frame
up to 2 years
Title
Overall Survival
Description
Overall survival considered all deaths, and time was calculated from randomisation to death.
Time Frame
2 years after the end of the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Come Lepage, Pr
Organizational Affiliation
Federation Francophone de Cancerologie Digestive
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Universitaire saint-Luc
City
Bruxelles
Country
Belgium
Facility Name
CHU d'Angers - Hôtel Dieu
City
Angers
Country
France
Facility Name
CHU - Hôpital Avicenne
City
Bobigny
Country
France
Facility Name
CHU Côte de Nacre
City
Caen
Country
France
Facility Name
CHU Estaing
City
Clermont Ferrand
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
Country
France
Facility Name
CHU Le Bocage Service d'HGE
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
CH Les Oudairies
City
La Roche Sur Yon
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
Country
France
Facility Name
CHU La Timone
City
Marseille
Country
France
Facility Name
Hôpital de la Source
City
Orléans
Country
France
Facility Name
CHU Cochin
City
Paris
Country
France
Facility Name
Hôpital Haut Lévêque Bat Magellan, Service d'hépato-gastroentérologie
City
Pessac
Country
France
Facility Name
Hôpital de la Milétrie
City
Poitiers
Country
France
Facility Name
Hôpital Robert Debré
City
Reims
Country
France
Facility Name
CHU de Rennes - Hôpital Pontchaillou
City
Rennes
Country
France
Facility Name
CHU Charles Nicolle
City
Rouen
Country
France
Facility Name
CHU de Saint Etienne
City
Saint Priest En Jarez
Country
France
Facility Name
Hôpital Rangueil
City
Toulouse
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Facility Name
Charite Campus Virchow Kilikum
City
Berlin
Country
Germany
Facility Name
University Hospital Marburg
City
Marburg
Country
Germany
Facility Name
Royal Free Hospital Neuroendocrine Tumour Unit
City
London
Country
United Kingdom
Facility Name
Manchester Academic Health Sciences Centre (MAHSC)
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28292641
Citation
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.
Results Reference
background
PubMed Identifier
6087395
Citation
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.
Results Reference
result
PubMed Identifier
36087395
Citation
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.
Results Reference
derived

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

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