Somatostatin Analogues for Neuroendocrine Tumors
(REMAIN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether somatostatin analogues (SSAs), a type of medication, can manage neuroendocrine tumors more effectively than observation alone after certain radiation treatments. Participants will either receive SSA treatment or be monitored according to standard care guidelines. The trial targets individuals with specific neuroendocrine tumors, particularly those who have received or are receiving a specific radiation therapy called PRRT. For those with a confirmed diagnosis of a gastrointestinal or pancreatic neuroendocrine tumor that cannot be surgically removed, this trial might be suitable. As a Phase 3 trial, this research represents the final step before FDA approval, offering early access to potentially effective treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that somatostatin analogues are likely to be safe for humans?
Studies have shown that somatostatin analogues (SSAs) are generally well-tolerated by patients. These treatments reduce the production of certain hormones, helping to manage symptoms caused by neuroendocrine tumors. Research indicates that serious side effects are rare with these treatments. Some patients might experience mild side effects, but these are usually manageable. SSAs already treat conditions like acromegaly (a hormonal disorder) and hormone-secreting tumors, demonstrating a good safety record. For those considering joining a trial using SSAs, past studies suggest they are relatively safe.12345
Why do researchers think this study treatment might be promising for neuroendocrine tumors?
Most treatments for neuroendocrine tumors focus on surgery, chemotherapy, or radiation to manage the disease. However, somatostatin analogues (SSAs) are unique because they specifically mimic the action of the natural hormone somatostatin to inhibit excessive hormone secretion by the tumors. This targeted approach not only helps control symptoms but may also slow tumor growth. Researchers are excited about SSAs because they can be administered consistently over time and potentially offer a more tailored treatment option compared to conventional methods.
What evidence suggests that somatostatin analogues might be an effective treatment for neuroendocrine tumors?
Research has shown that somatostatin analogues (SSAs) can effectively treat neuroendocrine tumors (NETs). These medications can slow cancer growth and sometimes shrink tumors. They also help manage symptoms like diarrhea and flushing, common in people with NETs. Some studies have found that patients taking SSAs experienced a longer period without disease progression. In one study, no patients on SSA treatment experienced tumor growth or died from the disease, highlighting its potential to stabilize the condition. In this trial, one group of participants will receive SSAs, while another group will undergo observation according to current standard care guidelines. Overall, SSAs are a well-established treatment that can help control symptoms and affect tumor growth.678910
Who Is on the Research Team?
Nikolaos Trikalinos, MD, MS
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults with nonfunctional neuroendocrine tumors (carcinoid tumors) who have already received PRRT treatment. Participants should be in stable condition after PRRT and able to attend regular follow-ups.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive somatostatin analogues (SSAs) or are observed as per standard of care following PRRT
Follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Somatostatin Analogues
Trial Overview
The study compares two approaches after PRRT: continuing treatment with somatostatin analogues (SSAs) versus simply observing patients without further immediate medication. Patients are randomly assigned to one of these groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients will receive SSA as per standard of care, starting within 3 months after PRRT. SSA administration (route of administration, dosing, and adjustments) is not dictated by this protocol, and SSAs may be given indefinitely.
Patients will be treated according to current standard of care guidelines.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Curium US LLC
Industry Sponsor
Citations
Treatment Patterns of Long-Acting Somatostatin Analogs ...
Patterns of use and clinical outcomes with long-acting somatostatin analogues for neuroendocrine tumors: a nationwide French retrospective ...
Long-acting somatostatin analogs and well differentiated ...
Long-acting SSAs are an effective and safe initial therapy of patients with well differentiated NET, allowing tumor growth as well as symptoms ...
Somatostatin Analogs Show Promise in Small Pancreatic ...
Zero patients on SSA therapy experienced tumor progression or disease-related death. In contrast, over 1 in 5 patients (21.9%) in the ...
Sequencing of Somatostatin-Receptor–Based Therapies in ...
In many studies, including NETTER-1, long-acting SSAs were stopped more than 6 wk short-acting reported a response rate of 21% and median PFS ...
The Expanding Role of Somatostatin Analogs in ... - PMC - NIH
Somatostatin analogues have been used to treat the symptoms of NETs for decades and also have an antineoplastic effect, markedly prolonging progression-free ...
Somatostatin: What It Is, Function & Symptoms
Neuroendocrine tumors (NETs). The primary function of somatostatin is to prevent the production of other hormones in your endocrine system and ...
Radiolabeled somatostatin analog [177Lu-DOTA0,Tyr3 ...
Treatment with 177Lu-octreotate results in tumor remission in a high percentage of patients with GEP tumors. Serious side effects are rare.
Somatostatin | Hormones
Excessive somatostatin levels in the bloodstream may be caused by a rare endocrine tumour that produces somatostatin, called a 'somatostatinoma'.
Physiology of somatostatin and its analogs
The development of synthetic analogs has led to treatment of clinical disorders such as acromegaly, hormone-secreting tumors of the ...
Somatostatin
Lanreotide (Somatuline, Ipsen Pharmaceuticals) is a medication used in the management of acromegaly and symptoms caused by neuroendocrine tumors, most notably ...
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