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

NCT ID: NCT04140409

Last Updated: 2019-10-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-02
• Study Completion Date: 2019-09-19

Brief Summary

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.

Conditions

Neuroendocrine Tumors; Carcinoid Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

All patients will be treated with octreotide LAR intramuscular injections at maximum doses of 60 mg every 4 weeks or a frequency up to 30 mg octreotide LAR each 2 weeks. Change of dose or frequency is left at the discretion of the investigator until symptom control is obtained.

Group Type: EXPERIMENTAL

Sandostatin

Intervention Type: DRUG

All patients will be treated with octreotide LAR intramuscular injections at maximum doses of 60 mg every 4 weeks or a frequency up to 30 mg octreotide LAR each 2 weeks. Change of dose or frequency is left at the discretion of the investigator until symptom control is obtained.

Interventions

Sandostatin

All patients will be treated with octreotide LAR intramuscular injections at maximum doses of 60 mg every 4 weeks or a frequency up to 30 mg octreotide LAR each 2 weeks. Change of dose or frequency is left at the discretion of the investigator until symptom control is obtained.

Intervention Type: DRUG

Other Intervention Names

Octreotide LAR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ivan Borbath, Prof

Role: PRINCIPAL_INVESTIGATOR

Cliniques Universitaires St-Luc

Other Identifiers

SCIROCCO

Identifier Type: -

Identifier Source: org_study_id