RECRUITING

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

Conditions

Pancreatic Carcinoma Pancreatic Neoplasm

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-05-09

Study Completion:2027-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06807437

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Jonathan G Sham

PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Study Locations (Sites)

UC San Diego Moores Cancer Center

La Jolla, California, 92093

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

Northwestern University

Chicago, Illinois, 60611

United States

University of Illinois

Chicago, Illinois, 60612

United States

Christiana Care - Union Hospital

Elkton, Maryland, 21921

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

Cross Lake, 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

Missouri Baptist Medical Center

Saint Louis, Missouri, 63131

United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

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

Saint Barnabas Medical Center

Livingston, New Jersey, 07039

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, 58103

United States

Essentia Health - Jamestown Clinic

Jamestown, North Dakota, 58401

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

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

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298

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

Collaborators and Investigators

Sponsor: SWOG Cancer Research Network

Jonathan G Sham, PRINCIPAL_INVESTIGATOR, SWOG Cancer Research Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-09

Study Completion Date2027-11-01

Study Record Updates

Study Start Date2025-05-09

Study Completion Date2027-11-01

Terms related to this study

Additional Relevant MeSH Terms

Pancreatic Carcinoma
Pancreatic Neoplasm