This is a prospective, multicenter, open-label study designed to evaluate the specificity and sensitivity of the Inflammation Based Index (IBI) score as a marker for predicting clinical and radiological response in patients treated with Lu-177 oxodotreotide for inoperable or metastatic, progressive, grade 1 or 2 intestinal neuroendocrine tumors. This IBI score will be assessed on the basis of C-reactive protein (CRP) and albumin values, and will be defined as follows: * IBI = 0: Low mortality risk (if CRP and serum albumin values are considered normal in the investigator's judgment). * IBI \> 0, including: IBI = 1: Intermediate risk of mortality (if one of the two values is considered abnormal and clinically significant according to the investigator's judgment (either hypoalbuminemia or elevated CRP)); IBI = 2: High mortality risk (if both values are considered abnormal and clinically significant according to the investigator's judgment (hypoalbuminemia and elevated CRP)). Patients were followed up for 36 months. A total of 150 patients should be included in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
150
These blood tests will be carried out on several occasions (before, during and after treatment with Lu-177 oxodotreotide). No additional blood sampling is required. In addition, patient clinical data and imaging data (standard examinations: thoraco-abdomino-pelvic CT +/- MRI and Ga-68 DOTA PET-CT) will be specifically collected for study purposes. For IUCT-O patients only: blood samples may be taken (at cycles 1 and 2, then 12 months after inclusion) for bio-banking purposes.
Institut de Cancérologie de l'Ouest
Angers, France
NOT_YET_RECRUITINGCHU de Bordeaux
Bordeaux, France
RECRUITINGCentre François Baclesse
Caen, France
RECRUITINGCHU de Lille
Lille, France
RECRUITINGCHU de Lyon
Lyon, France
RECRUITINGHôpital La Timone
Marseille, France
RECRUITINGInstitut de Cancérologie de Montpellier
Montpellier, France
RECRUITINGCHU Hôtel Dieu
Nantes, France
RECRUITINGCHU de Poitiers
Poitiers, France
RECRUITINGIUCT-O
Toulouse, France
RECRUITINGSensitivity, defined as the ratio of the number of refractory patients with an IBI score > 0 to the number of refractory patients.
Time frame: 12 months for each patient
Specificity, defined as the ratio of the number of non-refractory patients with an IBI score = 0 to the number of non-refractory patients.
Time frame: 12 months for each patient
The sensitivity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint.
Time frame: 36 months for each patient
The specificity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint.
Time frame: 36 months for each patient
Clinico-pathological parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.
Time frame: 36 months for each patient
Imaging parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.
Time frame: 36 months for each patient
Progression-free survival (PFS) rates (time from inclusion to progression or death from any cause) will be estimated with their 95% confidence intervals using the Kaplan-Meier method.
Time frame: 36 months for each patient
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