Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimis… (NCT04140409) | Clinical Trial Compass
TerminatedPhase 4
Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation
Stopped: Slow recruitment
10 participantsStarted 2016-02-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment succes vs treatment failure
Timeframe: 2 years
Trial details
NCT IDNCT04140409
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain