Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation

Phase 4TerminatedNCT04140409

Cliniques universitaires Saint-Luc- Université Catholique de Louvain10 enrolled

Overview

This is a multi-centric prospective interventional study in which patients with a symptomatic GEP-NET will receive octreotide LAR every 2, 3 or 4 weeks. The basal dose and the dose adaptation will be left at the discretion of the investigator depending on the rate of symptom control. Dose increase up to doses of 60 mg octreotide every 4 weeks, or increase of frequency up to 30 mg every 2 weeks can be done to obtain control of carcinoid symptoms, defined by at least a 50% decrease of the mean number of bowel movements per day and the total number of flushes over 7 days AND a maximum frequency of less than 4 bowel movements a day. If only one symptom is present, analysis will be done for that symptom only: refer to table in statistical analysis The concentration of serum octreotide level will be realized with LCMS/MS following the method of Capron \& Wallemacq. Each blood sample should be taken 4 times per year just before the next injection of Octreotide LAR.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuroendocrine Tumors Carcinoid Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent GEP NET Ki 67 ≤ 10 % * Histologically or cytologically confirmed GEP NET * Appearance of carcinoid syndrome maximum 6 months before the inclusion * Evaluable or measurable disease (RECIST 1.1) WHO ECOG performance status 0-2 * Positive somatostatin receptor scintigraphy * \>18 years * Life expectancy of at least 12 weeks Exclusion Criteria: * Uncontrolled concurrent disease which prevents the adequate management and follow-up of the NET. * Previous malignancy in the last past 3 years except malignancies estimated as completely cured. * Current pregnancy or breast feeding * Concomitant anti-tumoral treatment, except external beam radiotherapy

Outcomes

Primary Outcomes

Treatment succes vs treatment failure

The primary endpoint is defined as follows: * Treatment success: Symptom control is achieved within 2 years of treatment with octreotide LAR. Symptom control is defined as at least a 50% decrease of the mean number of bowel movements per day and the total number of flushes over 7 days AND a maximum frequency of less than 4 bowel movements a day. * Treatment failure: No symptom control is achieved within 2 years of treatment with octreotide LAR. The response rate will be calculated as the number of patients with treatment success divided by the total number of included patients that received at least one injection of octreotide LAR.

Time frame: 2 years

Secondary Outcomes

Symptoms

To describe the number of symptoms in correlation to the serum octreotide level, defined by a blood level test of octreotide.

Time frame: 2 years

Rate of diarrhea and flushes

To describe the rate of diarrhea and flushing via a patient diary

Time frame: 2 years

Impact of increased dose

To describe the impact of increased dose of octreotide LAR on the symptoms: bowel movements and flushing (via patient diary).

Time frame: 2 years

Changes in Quality of life

To describe the effect of Octreotide LAR on Quality of Life, based on the change from baseline in the OLO-GINET21 scores

Time frame: 2 years

Effect on tumor control

To describe the effect of Octreotide LAR on tumor control according to RECIST 1.1 criteria •

Time frame: 2 years

Toxicities

To describe the safety of octreotide (CTCAE grades)

Time frame: 2 years

Correlation dose/frequency

To describe the correlation between the dose/frequency of octreotide LAR given and the serum octreotide level.

Time frame: 2 years