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
|Condition or disease||Intervention/treatment||Phase|
|Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours||Drug: lanreotide Drug: Placebo||Phase 2 Phase 3|
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.
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.
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
In this arm, patients will receive lanreotide 120 mg every 28 days until disease progression
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
- 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)
- 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)
- 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
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
|Contact: Lila GABA||+33 3 80 39 34 email@example.com|
|Principal Investigator:||Come Lepage, Pr||Federation Francophone de Cancerologie Digestive|