a study evaluating lanreotide as maintenance therapy in patients with non-resectable duodeno-pancreatic neuroendocrine tumors (reminet)

Conditions: Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours

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.

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.

Eligibility criteria:
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.

Keywords: lanreotide duodeno-pancreatic neuroendocrine tumours maintenance treatment