Clinical Trial: A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 T
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 Summary:
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.
Sponsor: Federation Francophone de Cancerologie Digestive
Current Primary Outcome: Rate of patients alive and progression free at 6 months [ Time Frame: estimated 6 months after the last patient is randomized ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: Federation Francophone de Cancerologie Digestive
Dates:
Date Received: September 23, 2014
Date Started: September 2014
Date Completion: January 2024
Last Updated: August 10, 2016
Last Verified: May 2016