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

Primary Purpose

Neuroendocrine Tumors, Carcinoid Syndrome

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sandostatin
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring NET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Symptoms
    To describe the number of symptoms in correlation to the serum octreotide level, defined by a blood level test of octreotide.
    Rate of diarrhea and flushes
    To describe the rate of diarrhea and flushing via a patient diary
    Impact of increased dose
    To describe the impact of increased dose of octreotide LAR on the symptoms: bowel movements and flushing (via patient diary).
    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
    Effect on tumor control
    To describe the effect of Octreotide LAR on tumor control according to RECIST 1.1 criteria •
    Toxicities
    To describe the safety of octreotide (CTCAE grades)
    Correlation dose/frequency
    To describe the correlation between the dose/frequency of octreotide LAR given and the serum octreotide level.

    Full Information

    First Posted
    October 22, 2019
    Last Updated
    October 24, 2019
    Sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04140409
    Brief Title
    Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation
    Acronym
    SCIROCCO
    Official Title
    Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation A Prospective Interventional Trial of Patients With Neuro-endocrine Tumors With Carcinoid Syndrome Receiving Octreotide LAR
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Terminated
    Why Stopped
    Slow recruitment
    Study Start Date
    February 2, 2016 (Actual)
    Primary Completion Date
    June 30, 2019 (Actual)
    Study Completion Date
    September 19, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neuroendocrine Tumors, Carcinoid Syndrome
    Keywords
    NET

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Name(s)
    Sandostatin
    Other Intervention Name(s)
    Octreotide LAR
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Treatment succes vs treatment failure
    Description
    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 Outcome Measure Information:
    Title
    Symptoms
    Description
    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
    Title
    Rate of diarrhea and flushes
    Description
    To describe the rate of diarrhea and flushing via a patient diary
    Time Frame
    2 years
    Title
    Impact of increased dose
    Description
    To describe the impact of increased dose of octreotide LAR on the symptoms: bowel movements and flushing (via patient diary).
    Time Frame
    2 years
    Title
    Changes in Quality of life
    Description
    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
    Title
    Effect on tumor control
    Description
    To describe the effect of Octreotide LAR on tumor control according to RECIST 1.1 criteria •
    Time Frame
    2 years
    Title
    Toxicities
    Description
    To describe the safety of octreotide (CTCAE grades)
    Time Frame
    2 years
    Title
    Correlation dose/frequency
    Description
    To describe the correlation between the dose/frequency of octreotide LAR given and the serum octreotide level.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ivan Borbath, Prof
    Organizational Affiliation
    Cliniques Universitaires St-Luc
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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