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A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula
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. It may help stop the body from making extra amounts of certain hormones, including growth hormone, insulin, glucagon, and hormones that affect digestion. It may also help keep certain types of tumor cells from growing. Patients with pancreatic cancer or pancreatic lesions may undergo surgery to remove parts of the pancreas, also called a distal pancreatectomy. Patients may experience complications after surgery, including pancreatic fistulas. A pancreatic fistula occurs when there is a small leak from the pancreas, causing fluids to collect. This can often lead to infection and other problems. Giving lanreotide before undergoing distal pancreatectomy may be more effective than surgery alone in preventing the development of a pancreatic fistula in patients with pancreatic cancer or a pancreatic lesion that could become cancerous.
Eligibility Criteria
Inclusion Criteria
- 1Participants must have histologically or radiographically confirmed diagnosis of pancreatic cancer or a pancreatic lesion with malignant potential
- 2Participants must have an elective distal pancreatectomy planned to occur within 60 days after registration/randomization date
- 3Participants must not have a known history of a prior diagnosis of malabsorption syndrome
- 4Participants must not have been treated with any somatostatin analogue within 180 days prior to registration/randomization
- 5Participants must not have been treated with radiation therapy for their pancreas malignancy at any time prior to registration/randomization
- 6Participants must not have been treated with peptide receptor radionuclide therapy (PRRT) at any time prior to registration/randomization
- 7Participants must be ≥ 18 years old
- 8Participants must have a complete documented medical history and physical exam within 28 days prior to registration/randomization
- 9Participants 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 registration/randomization
- 10Participants 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 with known interactions with lanreotide may remain eligible if appropriate monitoring and management are in place. These medications include:
- 11Diabetes medications (insulin or oral hypoglycemics): Blood sugar will be monitored, and medication dose adjustments made as needed
- 12Cyclosporine: Dosage adjustments may be required to maintain therapeutic levels
- 13Bromocriptine: Dose adjustments may be considered to account for absorption changes
- 14Heart medications (e.g., beta blockers): Heart rate will be monitored, and medication doses adjusted if necessary
- 15CYP3A4-metabolized medications: Dose adjustments may be considered to avoid increased exposure
- 16In 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., stomach, colon, etc.) at the time of distal pancreatectomy
- 17NOTE: planned removal of the gallbladder or spleen at the time of distal pancreatectomy is not considered multivisceral resection and is permissible
- 18In the opinion of the treating surgeon, based on preoperative data, the participant must not require a tumor enucleation
- 19Participants 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 alanine aminotransferase \[ALT\] \> 320 U/L) within 60 days prior to registration/randomization. Transient elevation at the time of screening that resolves prior to study enrollment is acceptable
- 20Participants 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)
- 21Individuals 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 provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
- 22Participants must be offered the opportunity to participate in specimen banking
- 23Participants 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
- 24NOTE: 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 entered in the system.
- 25Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- 26For 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 Central Institutional Review Board (CIRB) regulations
Locations
93 sites participating in this study
Emory University Hospital Midtown
Atlanta, Georgia 30308
Seth Concors
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Seth Concors
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Seth Concors