Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours Clinical Trial
— REMINETOfficial 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
| Verified date | December 2022 |
| Source | Federation Francophone de Cancerologie Digestive |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 53 |
| Est. completion date | January 2020 |
| Est. primary completion date | January 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Clinique Universitaire saint-Luc | Bruxelles | |
| France | 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 Cedex | |
| 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 | |
| Germany | Charite Campus Virchow Kilikum | Berlin | |
| Germany | University Hospital Marburg | Marburg | |
| United Kingdom | Royal Free Hospital Neuroendocrine Tumour Unit | London | |
| United Kingdom | Manchester Academic Health Sciences Centre (MAHSC) | Manchester |
| Lead Sponsor | Collaborator |
|---|---|
| Federation Francophone de Cancerologie Digestive |
Belgium, France, Germany, United Kingdom,
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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 6 months | |
| Secondary | 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 |
up to 2 years | |
| Secondary | Overall Survival | Overall survival considered all deaths, and time was calculated from randomisation to death. | 2 years after the end of the treatment |