A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET) (REMINET)
|ClinicalTrials.gov Identifier: NCT02288377|
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : March 30, 2020
|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)|
|Actual Enrollment :||53 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|
|Actual Primary Completion Date :||January 2020|
|Actual Study Completion Date :||January 2020|
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)
- The toxicities [ Time Frame: estimated 6 months after the last patient is randomized ]Description using the NCI-CTC AE version 4.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288377
|Principal Investigator:||Come Lepage, Pr||Federation Francophone de Cancerologie Digestive|