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NCT06807437PHASE3Recruiting

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

SWOG Cancer Research Network

Start Date

5/9/2025

Completion Date

11/1/2027

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.

Detailed Description

PRIMARY OBJECTIVE: I. To compare the incidence of postoperative pancreatic fistula (POPF) occurring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo prior to undergoing distal pancreatectomy for biopsy-proven or suspected neoplasm. SECONDARY OBJECTIVES: I. To compare the incidence of International Study Group of Pancreatic Surgery (ISGPS)-defined biochemical leak occurring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo in the subset of participants with a drain placed. II. To compare the number of postoperative days in the hospital within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo. III. To compare change from baseline in cancer-specific quality of life at 14 and 60 days after surgery, as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30-(C30), in participants randomized to receive preoperative lanreotide versus placebo. ADDITIONAL OBJECTIVES: I. To compare change from baseline in pancreatic cancer-specific quality of life and overall health-related quality of life at 14 and 60 days after surgery, as measured by the EORTC QLQ- Pancreatic Cancer 26 (PAN26) and European Quality of Life Five Dimension Five Level (EQ-5D-5L), in participants randomized to receive preoperative lanreotide versus placebo. II. To compare the proportions of participants with common postoperative sequelae associated with POPF, including ISGPS delayed gastric emptying and ISGPS post pancreatectomy hemorrhage (grades B/C) occurring within 60 days after surgery, in participants randomized to receive preoperative lanreotide versus placebo. III. To compare time from surgery to initiation of adjuvant chemotherapy among participants with pancreatic ductal adenocarcinoma and planned adjuvant chemotherapy randomized to receive preoperative lanreotide versus placebo. BANKING OBJECTIVE: I. To bank blood, pancreas fluid, and tissue specimens for future correlative studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive lanreotide subcutaneously (SC) over 20 seconds and within 36 hours of planned distal pancreatectomy. Patients also undergo blood sample collection immediately prior to surgery and on post-operative days 1 and 3. Additionally, patients may undergo collection of pancreas fluid on post-operative days 1 and 3. ARM II: Patients receive saline placebo SC over 20 seconds and within 36 hours of planned distal pancreatectomy. Patients also undergo blood sample collection immediately prior to surgery and post-operatively on days 1 and 3. Additionally, patients may undergo collection of pancreas fluid on post-operative days 1 and 3. After completion of study treatment, patients are followed up at 4, 8 and 12 months after surgery.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

PROCEDURE

Biospecimen Collection

PROCEDURE

Distal Pancreatectomy

DRUG

Lanreotide

OTHER

Questionnaire Administration

OTHER

Saline

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Conditions

Pancreatic CarcinomaPancreatic Neoplasm

Locations

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama 35233

United States

Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis

Daphne, Alabama 36526

United States

Thomas Hospital

Fairhope, Alabama 36532

United States

Mobile Infirmary Medical Center

Mobile, Alabama 36607

United States

Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland

Saraland, Alabama 36571

United States

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234

United States

City of Hope Comprehensive Cancer Center

Duarte, California 91010

United States

UC San Diego Moores Cancer Center

La Jolla, California 92093

United States

Veterans Affairs Loma Linda Healthcare System

Loma Linda, California 92357

United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

UC San Diego Medical Center - Hillcrest

San Diego, California 92103

United States

Helen F Graham Cancer Center

Newark, Delaware 19713

United States

Medical Oncology Hematology Consultants PA

Newark, Delaware 19713

United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware 19718

United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware 19801

United States

Moffitt Cancer Center at SouthShore

Ruskin, Florida 33570

United States

Moffitt Cancer Center-International Plaza

Tampa, Florida 33607

United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida 33612

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida 33544

United States

Grady Health System

Atlanta, Georgia 30303

United States

Emory University Hospital Midtown

Atlanta, Georgia 30308

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

United States

Emory Saint Joseph's Hospital

Atlanta, Georgia 30342

United States

Emory Johns Creek Hospital

Johns Creek, Georgia 30097

United States

Northwestern University

Chicago, Illinois 60611

United States

University of Illinois

Chicago, Illinois 60612

United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois 60134

United States

Northwestern Medicine Oak Brook

Oak Brook, Illinois 60523

United States

Northwestern Medicine Orland Park

Orland Park, Illinois 60462

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois 60555

United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana 46202

United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky 40536

United States

University Medical Center New Orleans

New Orleans, Louisiana 70112

United States

Christiana Care - Union Hospital

Elkton, Maryland 21921

United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan 48109

United States

Bronson Battle Creek

Battle Creek, Michigan 49017

United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan 49503

United States

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

Grand Rapids, Michigan 49503

United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan 49503

United States

Trinity Health Muskegon Hospital

Muskegon, Michigan 49444

United States

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan 49120

United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan 49444

United States

Corewell Health Reed City Hospital

Reed City, Michigan 49677

United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan 49085

United States

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan 49085

United States

University of Michigan Health - West

Wyoming, Michigan 49519

United States

Riverwood Healthcare Center

Aitkin, Minnesota 56431

United States

Essentia Health - Baxter Clinic

Baxter, Minnesota 56425

United States

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota 56401

United States

Essentia Health - Saint Joseph's Crosslake Clinic

Crosslake, Minnesota 56442

United States

Essentia Health - Deer River Clinic

Deer River, Minnesota 56636

United States

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota 56501

United States

Essentia Health Cancer Center

Duluth, Minnesota 55805

United States

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota 55805

United States

Miller-Dwan Hospital

Duluth, Minnesota 55805

United States

Essentia Health - Ely Clinic

Ely, Minnesota 55731

United States

Essentia Health - Fosston

Fosston, Minnesota 56542

United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota 55746

United States

Essentia Health - International Falls Clinic

International Falls, Minnesota 56649

United States

Essentia Health - Moose Lake Clinic

Moose Lake, Minnesota 55767

United States

Essentia Health - Park Rapids

Park Rapids, Minnesota 56470

United States

Essentia Health - Saint Joseph's Pequot Lakes Clinic

Pequot Lakes, Minnesota 56472

United States

Essentia Health - Saint Joseph's Pine River Clinic

Pine River, Minnesota 56474

United States

Essentia Health Sandstone

Sandstone, Minnesota 55072

United States

Essentia Health - Saint Joseph's Staples Clinic

Staples, Minnesota 56479

United States

Essentia Health Virginia Clinic

Virginia, Minnesota 55792

United States

Parkland Health Center - Farmington

Farmington, Missouri 63640

United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri 63670

United States

Missouri Baptist Medical Center

St Louis, Missouri 63131

United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri 63080

United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri 63127

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Renown Regional Medical Center

Reno, Nevada 89502

United States

Saint Barnabas Medical Center

Livingston, New Jersey 07039

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08903

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico 87106

United States

University of Rochester

Rochester, New York 14642

United States

State University of New York Upstate Medical University

Syracuse, New York 13210

United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina 28203

United States

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina 28025

United States

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota 58103

United States

Sanford Broadway Medical Center

Fargo, North Dakota 58122

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota 58122

United States

Essentia Health - Jamestown Clinic

Jamestown, North Dakota 58401

United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio 45219

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio 43210

United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio 45069

United States

Saint Luke's Cancer Center - Allentown

Allentown, Pennsylvania 18104

United States

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania 18015

United States

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania 19317

United States

Saint Luke's Hospital-Anderson Campus

Easton, Pennsylvania 18045

United States

Saint Luke's Hospital - Upper Bucks Campus

Quakertown, Pennsylvania 18951

United States

Saint Luke's Hospital - Monroe Campus

Stroudsburg, Pennsylvania 18360

United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania 18711

United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota 57104

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota 57117-5134

United States

University of Tennessee - Knoxville

Knoxville, Tennessee 37920

United States

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee 38120

United States

University of Vermont Medical Center

Burlington, Vermont 05401

United States

University of Vermont and State Agricultural College

Burlington, Vermont 05405

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia 23235

United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia 23298

United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia 24033

United States

Valley Health / Winchester Medical Center

Winchester, Virginia 22601

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

University of Washington Medical Center - Montlake

Seattle, Washington 98195

United States

Duluth Clinic Ashland

Ashland, Wisconsin 54806

United States

Northwest Wisconsin Cancer Center

Ashland, Wisconsin 54806

United States

Essentia Health-Hayward Clinic

Hayward, Wisconsin 54843

United States

Tamarack Health Hayward Medical Center

Hayward, Wisconsin 54843

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin 54449

United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin 53149

United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin 53066

United States

Essentia Health-Spooner Clinic

Spooner, Wisconsin 54801

United States

Essentia Health Saint Mary's Hospital - Superior

Superior, Wisconsin 54880

United States

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin 53188

United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin 53188

United States