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RECRUITING

NCT06807437

PHASE3

Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula

Sponsor: SWOG Cancer Research Network

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

274

Start Date

2025-05-09

Completion Date

2027-11-01

Last Updated

2026-03-31

Healthy Volunteers

Conditions

Pancreatic Carcinoma Pancreatic Neoplasm

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample and pancreas fluid collection

PROCEDURE

Distal Pancreatectomy

Undergo distal pancreatectomy

DRUG

Lanreotide

Given SC

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Saline

Given SC

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

Locations (118)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis

Daphne, Alabama, United States

Thomas Hospital

Fairhope, Alabama, United States

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland

Saraland, Alabama, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Veterans Affairs Loma Linda Healthcare System

Loma Linda, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Moffitt Cancer Center at SouthShore

Ruskin, Florida, United States

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, United States

Grady Health System

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Emory Johns Creek Hospital

Johns Creek, Georgia, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Northwestern Medicine Oak Brook

Oak Brook, Illinois, United States

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Christiana Care - Union Hospital

Elkton, Maryland, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Bronson Battle Creek

Battle Creek, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, United States

Corewell Health Reed City Hospital

Reed City, Michigan, United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, United States

University of Michigan Health - West

Wyoming, Michigan, United States

Riverwood Healthcare Center

Aitkin, Minnesota, United States

Essentia Health - Baxter Clinic

Baxter, Minnesota, United States

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, United States

Essentia Health - Saint Joseph's Crosslake Clinic

Crosslake, Minnesota, United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota, United States

Essentia Health Cancer Center

Duluth, Minnesota, United States

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, United States

Miller-Dwan Hospital

Duluth, Minnesota, United States

Essentia Health - Ely Clinic

Ely, Minnesota, United States

Essentia Health - Fosston

Fosston, Minnesota, United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Essentia Health - International Falls Clinic

International Falls, Minnesota, United States

Essentia Health - Moose Lake Clinic

Moose Lake, Minnesota, United States

Essentia Health - Park Rapids

Park Rapids, Minnesota, United States

Essentia Health - Saint Joseph's Pequot Lakes Clinic

Pequot Lakes, Minnesota, United States

Essentia Health - Saint Joseph's Pine River Clinic

Pine River, Minnesota, United States

Essentia Health Sandstone

Sandstone, Minnesota, United States

Essentia Health - Saint Joseph's Staples Clinic

Staples, Minnesota, United States

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Parkland Health Center - Farmington

Farmington, Missouri, United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Renown Regional Medical Center

Reno, Nevada, United States

Saint Barnabas Medical Center

Livingston, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

University of Rochester

Rochester, New York, United States

State University of New York Upstate Medical University

Syracuse, New York, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, United States

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, United States

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Essentia Health - Jamestown Clinic

Jamestown, North Dakota, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

Saint Luke's Cancer Center - Allentown

Allentown, Pennsylvania, United States

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, United States

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, United States

Saint Luke's Hospital-Anderson Campus

Easton, Pennsylvania, United States

Saint Luke's Hospital - Upper Bucks Campus

Quakertown, Pennsylvania, United States

Saint Luke's Hospital - Monroe Campus

Stroudsburg, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

University of Tennessee - Knoxville

Knoxville, Tennessee, United States

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, United States

University of Vermont Medical Center

Burlington, Vermont, United States

University of Vermont and State Agricultural College

Burlington, Vermont, United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Valley Health / Winchester Medical Center

Winchester, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

University of Washington Medical Center - Montlake

Seattle, Washington, United States

Duluth Clinic Ashland

Ashland, Wisconsin, United States

Northwest Wisconsin Cancer Center

Ashland, Wisconsin, United States

Essentia Health-Hayward Clinic

Hayward, Wisconsin, United States

Tamarack Health Hayward Medical Center

Hayward, Wisconsin, United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Essentia Health-Spooner Clinic

Spooner, Wisconsin, United States

Essentia Health Saint Mary's Hospital - Superior

Superior, Wisconsin, United States

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Clinical Research Directory

Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (118)