Pancreatic Neuroendocrine Tumor
Conditions
Brief summary
The purpose of the protocol is to estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment, at 24 months after treatment initiation with lanreotide 120 mg every 28 days.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects aged ≥ 18 * Subjects diagnosed of functioning or non-functioning PanNET, G1/ G2 (Ki67≤10%) unresectable locally advanced tumour or metastatic disease, who have been treated with lanreotide 120mg every 28 days for at least 3 months and a maximum of 12 months * Subject not progressive at inclusion study visit according to investigator assessment, and using as a reference lanreotide initiation * Subject with Eastern Cooperative Oncology Group (ECOG) ≤2
Exclusion criteria
* Subject who is participating in an interventional study * Pregnant or breast-feeding women * Subject who has received any previous therapy for PanNET (such as octreotide LAR, Molecular Targeted Therapy (MTT), Peptide receptor radionuclide therapy (PRRT), chemotherapy, etc.) except short-acting octreotide subcutaneous (SC) used for symptomatic control of functioning tumours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) rate at 24 months | 24 months | To estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medical tumour-related intervention | Baseline | Description of the disease history management of subjects with PanNET will be collected by the investigator and recorded in an electronic CRF (eCRF) designed for the study |
| Time from diagnosis to first therapeutic intervention | Baseline | Description of the disease history management of subjects with PanNET |
| Quality of Life (QoL) | From baseline up to 24 months | To describe the change in Quality of Life (QoL) as assessed by European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaire for gastrointestinal neuroendocrine tumours (QLQ-GINET21) questionnaires.Where the patient assess experienced symptoms or problems using the scale from 1 to 4. Where 1 represents not at all and 4 very much. |
| Median time to lanreotide discontinuation | Up to 24 months | — |
| Progression-free survival (PFS) rate at 12 months | 12 months | PFS rate at 12 months after lanreotide treatment initiation according to investigator assessment |
| Changes of Glycated hemoglobin (HbA1c) levels | Every 6 months up to 24 months | Changes in HbA1c levels between last HbA1c value prior to lanreotide start (if available) and values at each study visit |
| Changes of urine 5-Hydroxyindoleacetic Acid (5-HIAA) levels | Every 6 months up to 24 months | Changes in 5-HIAA levels between last 5-HIAA value prior to lanreotide start (if available) and values at each study visit |
| Changes of pro-Brain Natriuretic Peptide (proBNP) levels | Every 6 months up to 24 months | Changes in proBNP levels between last proBNP value prior to lanreotide start (if available) and values at each study visit |
| Patient satisfaction | Baseline visit and 12 months | To evaluate patient' satisfaction (TSQM-9 questionnaire) at inclusion visit. Treatment Satisfaction Questionnaire for Medication (TSQM) is an instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. The effectiveness scored as: 1 (extremely dissatisfied) to 7 (extremely satisfied). For the convenience scored as 1(extremely difficult) to 7 (extremely easy). |
| Changes of Chromogranin A (CgA) levels | Every 6 months up to 24 months | Changes in CgA levels between last CgA value prior to lanreotide start (if available) and values at each study visit |
Countries
Portugal, Spain
Outcome results
None listed