Study on Lanreotide vs. Placebo Before Surgery to Prevent Pancreatic Fistulas
Sponsor: SWOG Cancer Research Network
ClinicalTrials ID:NCT06807437
This clinical trial is testing whether using the drug lanreotide before surgery can help prevent a complication called a pancreatic fistula in patients with pancreatic cancer or lesions that might become cancerous. A pancreatic fistula is a leak from the pancreas that can cause infections and other issues.
Patient Parameters
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Program Overview
The purpose of this study is to see if giving lanreotide, a drug similar to a hormone made by the body, before surgery can help prevent pancreatic fistulas in patients undergoing surgery for pancreatic cancer or potentially cancerous pancreatic lesions. Lanreotide may help stop the body from making extra hormones and could prevent certain tumor cells from growing. Patients with pancreatic cancer or lesions often have surgery to remove part of the pancreas, which can lead to complications like pancreatic fistulas. This study will compare the effects of lanreotide given before surgery to a placebo to see if it reduces the risk of developing a pancreatic fistula.
Description
The main goal of this study is to compare how often pancreatic fistulas occur within 60 days after surgery in patients who receive lanreotide before surgery versus those who receive a placebo. Secondary goals include comparing other complications, hospital stay length, and quality of life after surgery between the two groups.
Participants will be randomly assigned to one of two groups. One group will receive lanreotide, and the other will receive a placebo, both given as an injection before surgery. Blood and pancreas fluid samples will be collected before and after surgery to monitor the effects.
After the treatment, participants will have follow-up visits at 4, 8, and 12 months to check on their recovery and any long-term effects. The study also aims to collect blood and tissue samples for future research.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of pancreatic cancer or a pancreatic lesion that could become cancerous.
- Must be scheduled for elective surgery to remove part of the pancreas within 60 days of joining the study.
- Must not have a history of malabsorption syndrome.
- Must not have used somatostatin analogues in the last 180 days.
- Must not have received radiation therapy or peptide receptor radionuclide therapy for pancreatic cancer before joining the study.
- Must be 18 years or older.
- Must have a complete medical history and physical exam within 28 days before joining the study.
- Must have normal kidney function or a creatinine clearance of at least 50 mL/min.
- Must be able to manage medications that interact with lanreotide, such as diabetes or heart medications, with appropriate monitoring.
- Must not require certain types of complex surgery during the pancreatic surgery.
- Must not have severe liver problems.
- Must not be pregnant or nursing and must agree to use effective contraception during the study and for three months after.
- Must be willing to participate in specimen banking and quality-of-life assessments if eligible.
- Must understand the study and sign informed consent, or have a legally authorized representative do so if decision-making is impaired.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Mobile Infirmary Medical Center | 36607 | Mobile | Alabama |
| UC San Diego Moores Cancer Center | 92093 | La Jolla | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| UC San Diego Medical Center - Hillcrest | 92103 | San Diego | California |
| Helen F Graham Cancer Center | 19713 | Newark | Delaware |
| Medical Oncology Hematology Consultants PA | 19713 | Newark | Delaware |
| Christiana Care Health System-Christiana Hospital | 19718 | Newark | Delaware |
| Christiana Care Health System-Wilmington Hospital | 19801 | Wilmington | Delaware |
| Grady Health System | 30303 | Atlanta | Georgia |
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