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
About this trial
This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring NET
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
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
NCT ID
NCT04140409
First Posted
October 22, 2019
Last Updated
October 24, 2019
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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
We'll reach out to this number within 24 hrs