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

NCT06807437 · SWOG Cancer Research Network
In plain English

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Official title
A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula
About this study
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
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
Study design
Enrollment target: 274 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-05-09
Estimated completion: 2027-11-01
Last updated: 2026-03-31
Interventions
Procedure: Biospecimen CollectionProcedure: Distal PancreatectomyDrug: LanreotideOther: Questionnaire AdministrationOther: Saline
Primary outcomes
  • Incidence of postoperative pancreatic fistula (POPF) (Up to 60 days after distal pancreatectomy)
Sponsor
SWOG Cancer Research Network · network
With: National Cancer Institute (NCI)
Contacts & investigators
ContactAndrea Garcia · contact · agarcia@swog.org · 210-614-8808
ContactDana Sparks · contact · dsparks@swog.org · 210-614-8808
InvestigatorJonathan G Sham · principal_investigator, SWOG Cancer Research Network
All locations (118)
University of Alabama at Birmingham Cancer CenterSuspended
Birmingham, Alabama, United States
Gulf Health Hospitals Inc/Infirmary Cancer Care - MalbisSuspended
Daphne, Alabama, United States
Thomas HospitalSuspended
Fairhope, Alabama, United States
Mobile Infirmary Medical CenterSuspended
Mobile, Alabama, United States
Gulf Health Hospitals Inc/Infirmary Cancer Care - SaralandSuspended
Saraland, Alabama, United States
Banner MD Anderson Cancer CenterSuspended
Gilbert, Arizona, United States
City of Hope Comprehensive Cancer CenterSuspended
Duarte, California, United States
UC San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
Veterans Affairs Loma Linda Healthcare SystemSuspended
Loma Linda, California, United States
USC / Norris Comprehensive Cancer CenterSuspended
Los Angeles, California, United States
UC San Diego Medical Center - HillcrestSuspended
San Diego, California, United States
Helen F Graham Cancer CenterSuspended
Newark, Delaware, United States
Medical Oncology Hematology Consultants PASuspended
Newark, Delaware, United States
Christiana Care Health System-Christiana HospitalSuspended
Newark, Delaware, United States
Christiana Care Health System-Wilmington HospitalSuspended
Wilmington, Delaware, United States
Moffitt Cancer Center at SouthShoreSuspended
Ruskin, Florida, United States
Moffitt Cancer Center-International PlazaSuspended
Tampa, Florida, United States
Moffitt Cancer Center - McKinley CampusRecruiting
Tampa, Florida, United States
Moffitt Cancer CenterSuspended
Tampa, Florida, United States
Moffitt Cancer Center at Wesley ChapelSuspended
Wesley Chapel, Florida, United States
Grady Health SystemSuspended
Atlanta, Georgia, United States
Emory University Hospital MidtownSuspended
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer InstituteSuspended
Atlanta, Georgia, United States
Emory Saint Joseph's HospitalSuspended
Atlanta, Georgia, United States
Emory Johns Creek HospitalSuspended
Johns Creek, Georgia, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
University of IllinoisRecruiting
Chicago, Illinois, United States
Northwestern Medicine Cancer Center DelnorSuspended
Geneva, Illinois, United States
Northwestern Medicine Oak BrookSuspended
Oak Brook, Illinois, United States
Northwestern Medicine Orland ParkSuspended
Orland Park, Illinois, United States
Northwestern Medicine Cancer Center WarrenvilleSuspended
Warrenville, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer CenterSuspended
Indianapolis, Indiana, United States
University of Kentucky/Markey Cancer CenterRecruiting
Lexington, Kentucky, United States
University Medical Center New OrleansSuspended
New Orleans, Louisiana, United States
Christiana Care - Union HospitalSuspended
Elkton, Maryland, United States
University of Michigan Rogel Cancer CenterSuspended
Ann Arbor, Michigan, United States
Bronson Battle CreekSuspended
Battle Creek, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth HospitalSuspended
Grand Rapids, Michigan, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalSuspended
Grand Rapids, Michigan, United States
Trinity Health Grand Rapids HospitalSuspended
Grand Rapids, Michigan, United States
Trinity Health Muskegon HospitalSuspended
Muskegon, Michigan, United States
Corewell Health Lakeland Hospitals - Niles HospitalSuspended
Niles, Michigan, United States
Cancer and Hematology Centers of Western Michigan - Norton ShoresSuspended
Norton Shores, Michigan, United States
Corewell Health Reed City HospitalSuspended
Reed City, Michigan, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer CenterSuspended
Saint Joseph, Michigan, United States
Corewell Health Lakeland Hospitals - Saint Joseph HospitalSuspended
Saint Joseph, Michigan, United States
University of Michigan Health - WestSuspended
Wyoming, Michigan, United States
Riverwood Healthcare CenterSuspended
Aitkin, Minnesota, United States
Essentia Health - Baxter ClinicSuspended
Baxter, Minnesota, United States
Essentia Health Saint Joseph's Medical CenterSuspended
Brainerd, Minnesota, United States
Essentia Health - Saint Joseph's Crosslake ClinicSuspended
Crosslake, Minnesota, United States
Essentia Health - Deer River ClinicSuspended
Deer River, Minnesota, United States
Essentia Health Saint Mary's - Detroit Lakes ClinicSuspended
Detroit Lakes, Minnesota, United States
Essentia Health Cancer CenterSuspended
Duluth, Minnesota, United States
Essentia Health Saint Mary's Medical CenterSuspended
Duluth, Minnesota, United States
Miller-Dwan HospitalSuspended
Duluth, Minnesota, United States
Essentia Health - Ely ClinicSuspended
Ely, Minnesota, United States
Essentia Health - FosstonSuspended
Fosston, Minnesota, United States
Essentia Health Hibbing ClinicSuspended
Hibbing, Minnesota, United States
Essentia Health - International Falls ClinicSuspended
International Falls, Minnesota, United States
Essentia Health - Moose Lake ClinicSuspended
Moose Lake, Minnesota, United States
Essentia Health - Park RapidsSuspended
Park Rapids, Minnesota, United States
Essentia Health - Saint Joseph's Pequot Lakes ClinicSuspended
Pequot Lakes, Minnesota, United States
Essentia Health - Saint Joseph's Pine River ClinicSuspended
Pine River, Minnesota, United States
Essentia Health SandstoneSuspended
Sandstone, Minnesota, United States
Essentia Health - Saint Joseph's Staples ClinicSuspended
Staples, Minnesota, United States
Essentia Health Virginia ClinicSuspended
Virginia, Minnesota, United States
Parkland Health Center - FarmingtonRecruiting
Farmington, Missouri, United States
Sainte Genevieve County Memorial HospitalRecruiting
Sainte Genevieve, Missouri, United States
Missouri Baptist Medical CenterRecruiting
St Louis, Missouri, United States
Missouri Baptist Sullivan HospitalRecruiting
Sullivan, Missouri, United States
BJC Outpatient Center at Sunset HillsRecruiting
Sunset Hills, Missouri, United States
University of Nebraska Medical CenterSuspended
Omaha, Nebraska, United States
Renown Regional Medical CenterSuspended
Reno, Nevada, United States
Saint Barnabas Medical CenterSuspended
Livingston, New Jersey, United States
Rutgers Cancer Institute of New JerseySuspended
New Brunswick, New Jersey, United States
University of New Mexico Cancer CenterSuspended
Albuquerque, New Mexico, United States
University of RochesterSuspended
Rochester, New York, United States
State University of New York Upstate Medical UniversitySuspended
Syracuse, New York, United States
Carolinas Medical Center/Levine Cancer InstituteSuspended
Charlotte, North Carolina, United States
Atrium Health Cabarrus/LCI-ConcordSuspended
Concord, North Carolina, United States
Essentia Health Cancer Center-South University ClinicSuspended
Fargo, North Dakota, United States
Sanford Broadway Medical CenterSuspended
Fargo, North Dakota, United States
Sanford Roger Maris Cancer CenterSuspended
Fargo, North Dakota, United States
Essentia Health - Jamestown ClinicSuspended
Jamestown, North Dakota, United States
University of Cincinnati Cancer Center-UC Medical CenterSuspended
Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer CenterSuspended
Columbus, Ohio, United States
University of Cincinnati Cancer Center-West ChesterSuspended
West Chester, Ohio, United States
Saint Luke's Cancer Center - AllentownRecruiting
Allentown, Pennsylvania, United States
Saint Luke's University Hospital-Bethlehem CampusRecruiting
Bethlehem, Pennsylvania, United States
Christiana Care Health System-Concord Health CenterSuspended
Chadds Ford, Pennsylvania, United States
Saint Luke's Hospital-Anderson CampusRecruiting
Easton, Pennsylvania, United States
Saint Luke's Hospital - Upper Bucks CampusRecruiting
Quakertown, Pennsylvania, United States
Saint Luke's Hospital - Monroe CampusRecruiting
Stroudsburg, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer CenterSuspended
Wilkes-Barre, Pennsylvania, United States
Sanford Cancer Center Oncology ClinicSuspended
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux FallsSuspended
Sioux Falls, South Dakota, United States
University of Tennessee - KnoxvilleSuspended
Knoxville, Tennessee, United States
Baptist Memorial Hospital and Cancer Center-MemphisSuspended
Memphis, Tennessee, United States
University of Vermont Medical CenterSuspended
Burlington, Vermont, United States
University of Vermont and State Agricultural CollegeSuspended
Burlington, Vermont, United States
VCU Massey Cancer Center at Stony PointRecruiting
Richmond, Virginia, United States
VCU Massey Comprehensive Cancer CenterRecruiting
Richmond, Virginia, United States
Carilion Roanoke Memorial HospitalSuspended
Roanoke, Virginia, United States
Valley Health / Winchester Medical CenterSuspended
Winchester, Virginia, United States
Fred Hutchinson Cancer CenterSuspended
Seattle, Washington, United States
University of Washington Medical Center - MontlakeSuspended
Seattle, Washington, United States
Duluth Clinic AshlandSuspended
Ashland, Wisconsin, United States
Northwest Wisconsin Cancer CenterSuspended
Ashland, Wisconsin, United States
Essentia Health-Hayward ClinicSuspended
Hayward, Wisconsin, United States
Tamarack Health Hayward Medical CenterSuspended
Hayward, Wisconsin, United States
Marshfield Medical Center-MarshfieldRecruiting
Marshfield, Wisconsin, United States
ProHealth D N Greenwald CenterSuspended
Mukwonago, Wisconsin, United States
ProHealth Oconomowoc Memorial HospitalSuspended
Oconomowoc, Wisconsin, United States
Essentia Health-Spooner ClinicSuspended
Spooner, Wisconsin, United States
Essentia Health Saint Mary's Hospital - SuperiorSuspended
Superior, Wisconsin, United States
ProHealth Waukesha Memorial HospitalSuspended
Waukesha, Wisconsin, United States
UW Cancer Center at ProHealth CareSuspended
Waukesha, Wisconsin, United States
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula · TrialPath