Non-resectable duodeno-pancreatic neuroendocrine tumours after first line treatment MedDRA version: 20.0 Level: PT Classification code 10067517 Term: Pancreatic neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: SOMATULINE® LP 120 mg
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: LANREOTIDE
CAS Number: 108736-3
Sponsors
Fédération Francophone de Cancérologie Digestive (FFCD)
Eligibility
Sex/Gender
All
Inclusion 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%) •First-line treatment started due to (a, b OR c): a. Presence of symptomatic disease and/or hepatic invasion = 50% and/or bone metastasis b. Documented tumour progression before first line treatment c. Disease progression under Somatostatin analogues (analogues stopped prior to starting the 1st 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 targeted therapy (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 targeted therapy •Non-functional tumour or gastrinoma controlled by PPIs •Age > or = 18 years •WHO 0, 1 or 2 •Highly effective contraception for male or female patients of childbearing age, defined as: oral contraceptives, intra-uterine devices or surgical sterilisation (vasectomy, tubal ligation). 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 111 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 111
Exclusion criteria
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 •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. •Employment of the subject or a close relative (i.e. spouse/partner, child, parent or sibling) by the CRO, the study site •Patients deprived of their liberty by a judicial or administrative decision, patients admitted to a hospital, social institution or who are under a measure of legal protection, patients hospitalized without consent or who are in an emergency situation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase II: To evaluate the rate of patients alive and progression free at 6 months, assessed by the investigator according to RECIST criteria, version 1.1. Phase III: To assess and compare the Progression Free Survival (PFS) of lanreotide versus placebo according to RECIST criteria (version 1.1, Appendix 3), assessed by the investigator. ; Secondary Objective: Phase II: •Rate of patients alive and progression free at 12 months, assessed by the investigator according to RECIST criteria (version 1.1) •Rate of patients alive and progression free at 6 months, according to central review •Safety •Response rate at 6 months according to RECIST criteria (version 1.1) •Time To Progression (TTP) •Quality of life assessed with the questionnaire QLQ-C30, including module NET 21, and the Spitzer visual analogue scale. Phase III: •Overall Survival (OS) at 3 and 5 years •PFS according to central review •Safety •Response rate at 6 months according to RECIST criteria (version 1.1) •Chemotherapy / targeted therapy-free time interval •Quality of life assessed with the questionnaire QLQ-C30, including module NET 21, and the Spitzer visual analogue scale. •Medico-economical evaluation: cost-effectiveness analysis at 12 months and cost-utility analysis at 18 months (using EQ-5D questionnaire). ; Primary end point(s): Phase II: The rate of patients alive and progression free at 6 months, evaluated according to the results of imaging assessment done 6 months after the randomisation. This evaluation will be done by the investigator according to RECIST criteria (version 1.1). Phase III: The progression fr | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase II: •Rate of patients alive and progression free at 12 months (according to RECIST criteria version 1.1), assessed by the investigator •Rate of patients alive and progression free at 6 months, according to central review •Safety: the toxicities will be described using the NCI-CTC AE version 4.0 •Response rate according to RECIST criteria at 6 months (version 1.1), according to the investigator. Response rate will be defined as complete or partial response to the treatment •Time to progression (median). This endpoint will be calculated from the randomisation date to the date of the first progression (clinical and radiological) according to the investigator •Quality of life (QLQ-C30 including module NET 21, the Spitzer visual analogue scale) will be described at each time-point. Phase III: The secondary endpoints of phase III will consist of the comparison between the placebo and the lanreotide, on: •Overall survival (OS) at 3 and 5 years. This endpoint will be estimated considering all deaths and the time will be calculated from the randomisation date to the date of death. Patients alive will be censored at the date of the last news or at the cut-off date •PFS according to central review, evaluated considering the first radiological progression of the patient (central review) or death (any reason). The time will be calculated from the randomisation date to the date the first event occurred. Patients alive and progression free will be censored at the date of the last news or at the cut-off date (the date the first of these occurs will be considered). •Safety: the toxicities will be described using the NCI-CTC AE version 4.0 •Response rate at 6 months according to RECIST criteria (version 1.1). Response rate will be defined as complete or partial res | — |
Countries
Belgium, Germany, Ireland, United Kingdom
Contacts
Public ContactPascale Brosset-Savigny
International Clinical Trials Association
Outcome results
None listed