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

Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Proportion of Patients Alive and Progression-free at 6 Months [6 months]. Count Of Participants, Participants. Placebo (n=24): 13; Lanreotide (n=26): 19.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression-Free Survival [up to 2 years]. Median, Months (95% Confidence Interval). Placebo (n=25): 7.6 (3.0 to 9.0); Lanreotide (n=27): 19.4 (7.6 to 32.6).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival [2 years after the end of the treatment]. Number, Percentage of patients alive (95% Confidence Interval). Placebo (n=25): 86.1 (62.1 to 95.4); Lanreotide (n=27): 95.0 (69.5 to 99.3).