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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion 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 registration/randomization
* 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 with known interactions with lanreotide may remain eligible if appropriate monitoring and management are in place. These medications include:
* 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., stomach, colon, etc.) at the time of distal pancreatectomy
* 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 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
* 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 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
* 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 entered in the system.
* 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 Central Institutional Review Board (CIRB) regulations
Primary outcome measure(s)
Incidence of postoperative pancreatic fistula (POPF) — Up to 60 days after distal pancreatectomy POPF will be assessed using the 2016 International Study Group for Pancreas Surgery (ISGPS). Incidence rates of POPF in each treatment arm will be described, and treatment arm differences assessed via logistic regression model with adjustment for stratification factor.
Trial sites (118)
Facility
City
Region
Status
University of Alabama at Birmingham Cancer Center
Birmingham
Alabama
Suspended
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne
Alabama
Suspended
Thomas Hospital
Fairhope
Alabama
Suspended
Mobile Infirmary Medical Center
Mobile
Alabama
Suspended
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Saraland
Alabama
Suspended
Banner MD Anderson Cancer Center
Gilbert
Arizona
Suspended
City of Hope Comprehensive Cancer Center
Duarte
California
Suspended
UC San Diego Moores Cancer Center
La Jolla
California
Recruiting
Veterans Affairs Loma Linda Healthcare System
Loma Linda
California
Suspended
USC / Norris Comprehensive Cancer Center
Los Angeles
California
Suspended
UC San Diego Medical Center - Hillcrest
San Diego
California
Suspended
Helen F Graham Cancer Center
Newark
Delaware
Suspended
Medical Oncology Hematology Consultants PA
Newark
Delaware
Suspended
Christiana Care Health System-Christiana Hospital
Newark
Delaware
Suspended
Christiana Care Health System-Wilmington Hospital
Wilmington
Delaware
Suspended
Moffitt Cancer Center at SouthShore
Ruskin
Florida
Suspended
Moffitt Cancer Center-International Plaza
Tampa
Florida
Suspended
Moffitt Cancer Center - McKinley Campus
Tampa
Florida
Recruiting
Moffitt Cancer Center
Tampa
Florida
Suspended
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel
Florida
Suspended
Grady Health System
Atlanta
Georgia
Suspended
Emory University Hospital Midtown
Atlanta
Georgia
Suspended
Emory University Hospital/Winship Cancer Institute
Atlanta
Georgia
Suspended
Emory Saint Joseph's Hospital
Atlanta
Georgia
Suspended
Emory Johns Creek Hospital
Johns Creek
Georgia
Suspended
Northwestern University
Chicago
Illinois
Recruiting
University of Illinois
Chicago
Illinois
Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva
Illinois
Suspended
Northwestern Medicine Oak Brook
Oak Brook
Illinois
Suspended
Northwestern Medicine Orland Park
Orland Park
Illinois
Suspended
Northwestern Medicine Cancer Center Warrenville
Warrenville
Illinois
Suspended
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis
Indiana
Suspended
University of Kentucky/Markey Cancer Center
Lexington
Kentucky
Recruiting
University Medical Center New Orleans
New Orleans
Louisiana
Suspended
Christiana Care - Union Hospital
Elkton
Maryland
Suspended
University of Michigan Rogel Cancer Center
Ann Arbor
Michigan
Suspended
Bronson Battle Creek
Battle Creek
Michigan
Suspended
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids
Michigan
Suspended
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids
Michigan
Suspended
Trinity Health Grand Rapids Hospital
Grand Rapids
Michigan
Suspended
+ 78 more sites — see the full list on the official registry below.
More SWOG Cancer Research Network trials in Mexico
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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