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Compares treatment options for Pancreatic Carcinoma
Official title Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
ClinicalTrials.gov ID: NCT06807437
What this study is testing
What is Lanreotide?
Lanreotide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for pancreatic carcinoma.
Also referred to as Angiopeptin, BIM-23014.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III trial compares the effect of using lanreotide before surgery to surgery alone in preventing pancreatic fistulas in patients with pancreatic cancer or a pancreatic lesion that could become cancerous. Lanreotide, a type of somatostatin analog similar to somatostatin (a hormone made by the body), and is used to treat certain types of gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically or radiographically confirmed diagnosis of pancreatic cancer or a pancreatic lesion with malignant potential
- Participants must have an elective distal pancreatectomy planned to occur within 60 days after registration/randomization date
- Participants must not have a known history of a prior diagnosis of malabsorption syndrome
- Participants must not have been treated with any somatostatin analogue within 180 days prior to registration/randomization
- Participants must not have been treated with radiation therapy for their pancreas malignancy at any time prior to registration/randomization
See the full eligibility criteria
- Participants must have histologically or radiographically confirmed diagnosis of pancreatic cancer or a pancreatic lesion with malignant potential
- Participants must have an elective distal pancreatectomy planned to occur within 60 days after registration/randomization date
- Participants must not have a known history of a prior diagnosis of malabsorption syndrome
- Participants must not have been treated with any somatostatin analogue within 180 days prior to registration/randomization
- Participants must not have been treated with radiation therapy for their pancreas malignancy at any time prior to registration/randomization
- Participants must not have been treated with peptide receptor radionuclide therapy (PRRT) at any time prior to registration/randomization
- Participants must be ≥ 18 years old
- Participants must have a complete documented medical history and physical exam within 28 days prior to registration/randomization
- Participants must have a creatinine ≤ the institutional upper limit of normal (IULN) OR a measured OR calculated creatinine clearance ≥ 50 mL/min using the following Cockcroft -Gault formula within 60 days prior to...
- Participants must complete a pre-registration screening to identify any of the medications below, allowing the study team and treating physician to develop a monitoring plan as needed. Participants taking medications...
- Diabetes medications (insulin or oral hypoglycemics): Blood sugar will be monitored, and medication dose adjustments made as needed
- Cyclosporine: Dosage adjustments may be required to maintain therapeutic levels
- Bromocriptine: Dose adjustments may be considered to account for absorption changes
- Heart medications (e.g., beta blockers): Heart rate will be monitored, and medication doses adjusted if necessary
- CYP3A4-metabolized medications: Dose adjustments may be considered to avoid increased exposure
- In the opinion of the treating surgeon, based on preoperative data, the participant must not require a modified Appleby-type procedure (distal pancreatectomy with celiac axis resection) or multivisceral resection (e.g...
- NOTE: planned removal of the gallbladder or spleen at the time of distal pancreatectomy is not considered multivisceral resection and is permissible
- In the opinion of the treating surgeon, based on preoperative data, the participant must not require a tumor enucleation
- Participants must not have moderate to severe hepatic impairment as defined by liver enzyme elevation more than 5 times the institutional upper limit of normal (either aspartate aminotransferase [AST] \> 190 U/L or...
- Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped)
- Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during the whole period of the study and for three months after the study drug administration, with details...
- Participants must be offered the opportunity to participate in specimen banking
- Participants who can complete EORTC QLQ-C30, EORTC QLQ-PAN26, and EQ-5D-5L forms in English or Spanish, must be offered the opportunity to participate in the quality-of-life study
- NOTE: As a part of the OPEN registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been...
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Daphne, Alabama, United States
- Fairhope, Alabama, United States
- Mobile, Alabama, United States
- Saraland, Alabama, United States
- Gilbert, Arizona, United States
- Duarte, California, United States
- La Jolla, California, United States
- Loma Linda, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Newark, Delaware, United States
- Wilmington, Delaware, United States
- Ruskin, Florida, United States
- Tampa, Florida, United States
- Wesley Chapel, Florida, United States
- Atlanta, Georgia, United States
- Johns Creek, Georgia, United States
- Chicago, Illinois, United States
- Geneva, Illinois, United States
+ 76 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Daphne, Alabama, United States; Fairhope, Alabama, United States; Mobile, Alabama, United States; Saraland, Alabama, United States; Gilbert, Arizona, United States and 90 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.