Lanreotide for Preventing Surgical Complications in Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether lanreotide, a medication, can prevent complications like pancreatic fistulas (a type of leakage from the pancreas) after surgery in individuals with pancreatic cancer or pre-cancerous lesions. Lanreotide stops the body from making extra hormones and may help prevent certain tumors from growing. Participants will receive either lanreotide or a placebo before their surgery. This trial may suit individuals with a confirmed diagnosis of pancreatic cancer or a lesion that could become cancerous, especially if surgery is planned soon. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
You may not need to stop your current medications, but if you are taking certain drugs like diabetes medications, cyclosporine, bromocriptine, heart medications, or those metabolized by CYP3A4, your doctor will monitor you and may adjust your doses as needed.
Is there any evidence suggesting that lanreotide is likely to be safe for humans?
Research has shown that lanreotide is generally safe for people. One study found that long-term use of lanreotide was safe and well-tolerated. Another study noted that lanreotide remains in the body for an extended period and has manageable side effects, making it suitable for use around surgery. Lanreotide is also used to treat certain tumors, suggesting its safety for similar conditions. While no treatment is without risks, existing studies provide reassuring evidence about lanreotide's safety in humans.12345
Why do researchers think this study treatment might be promising for pancreatic cancer?
Researchers are excited about lanreotide for pancreatic cancer surgery because it offers a new approach to preventing surgical complications. Unlike the standard of care, which often involves managing symptoms post-surgery, lanreotide is a somatostatin analog that targets and reduces the secretion of certain hormones and fluids that can lead to complications. This preemptive action could potentially lower the risk of issues like pancreatic fistulas, which are common after surgery. Additionally, lanreotide's subcutaneous delivery method allows for quick administration within 36 hours before surgery, aiming to enhance patient outcomes right from the start.
What evidence suggests that lanreotide might be an effective treatment for preventing surgical complications in pancreatic cancer?
This trial will compare lanreotide with a saline placebo in preventing surgical complications in pancreatic cancer. Studies have shown that lanreotide can help prevent problems after pancreas surgery. Specifically, patients who received lanreotide before their surgery had a pancreatic fistula rate of just 3%, lower than the rates seen with surgery alone. A pancreatic fistula is a leak from the pancreas that can cause infections. Lanreotide acts like somatostatin, a hormone that helps control digestion and may stop some tumor cells from growing. Research indicates that lanreotide can effectively reduce surgical complications, making it a promising option for those undergoing pancreas surgery.23678
Who Is on the Research Team?
Jonathan G Sham
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
This trial is for individuals with pancreatic cancer or lesions that could turn cancerous, who are planning to have part of their pancreas removed. They must not have malabsorption syndrome, should have normal kidney function or adequate creatinine clearance, and no prior treatments with somatostatin analogues within 180 days or radiation/PRRT for their pancreatic condition.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Treatment
Participants receive lanreotide or placebo subcutaneously within 36 hours of planned distal pancreatectomy
Surgery and Immediate Postoperative Care
Participants undergo distal pancreatectomy and immediate postoperative monitoring, including blood and pancreas fluid collection
Follow-up
Participants are monitored for safety and effectiveness, including incidence of postoperative pancreatic fistula and quality of life assessments
Long-term Follow-up
Participants are followed up at 4, 8, and 12 months after surgery for additional safety and quality of life assessments
What Are the Treatments Tested in This Trial?
Interventions
- Lanreotide
Find a Clinic Near You
Who Is Running the Clinical Trial?
SWOG Cancer Research Network
Lead Sponsor
National Cancer Institute (NCI)
Collaborator