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

Status: Recruiting
Location: See all (85) locations...
Intervention Type: Drug, Other, Procedure
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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
United States
Alabama
University of Alabama at Birmingham Cancer Center
RECRUITING
Birmingham
California
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
USC / Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
UC San Diego Medical Center - Hillcrest
RECRUITING
San Diego
Delaware
Christiana Care Health System-Christiana Hospital
RECRUITING
Newark
Helen F Graham Cancer Center
RECRUITING
Newark
Medical Oncology Hematology Consultants PA
RECRUITING
Newark
Christiana Care Health System-Wilmington Hospital
RECRUITING
Wilmington
Illinois
Northwestern University
RECRUITING
Chicago
University of Illinois
RECRUITING
Chicago
Northwestern Medicine Cancer Center Delnor
RECRUITING
Geneva
Northwestern Medicine Oak Brook
RECRUITING
Oak Brook
Northwestern Medicine Orland Park
RECRUITING
Orland Park
Northwestern Medicine Cancer Center Warrenville
RECRUITING
Warrenville
Indiana
Indiana University/Melvin and Bren Simon Cancer Center
RECRUITING
Indianapolis
Louisiana
University Medical Center New Orleans
RECRUITING
New Orleans
Maryland
Christiana Care - Union Hospital
RECRUITING
Elkton
Michigan
Bronson Battle Creek
RECRUITING
Battle Creek
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
RECRUITING
Grand Rapids
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
RECRUITING
Grand Rapids
Trinity Health Grand Rapids Hospital
RECRUITING
Grand Rapids
Trinity Health Muskegon Hospital
RECRUITING
Muskegon
Corewell Health Lakeland Hospitals - Niles Hospital
RECRUITING
Niles
Cancer and Hematology Centers of Western Michigan - Norton Shores
RECRUITING
Norton Shores
Corewell Health Reed City Hospital
RECRUITING
Reed City
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
RECRUITING
Saint Joseph
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
RECRUITING
Saint Joseph
University of Michigan Health - West
RECRUITING
Wyoming
Minnesota
Riverwood Healthcare Center
RECRUITING
Aitkin
Essentia Health - Baxter Clinic
RECRUITING
Baxter
Essentia Health Saint Joseph's Medical Center
RECRUITING
Brainerd
Essentia Health - Saint Joseph's Crosslake Clinic
RECRUITING
Crosslake
Essentia Health - Deer River Clinic
RECRUITING
Deer River
Essentia Health Saint Mary's - Detroit Lakes Clinic
RECRUITING
Detroit Lakes
Essentia Health Cancer Center
RECRUITING
Duluth
Essentia Health Saint Mary's Medical Center
RECRUITING
Duluth
Miller-Dwan Hospital
RECRUITING
Duluth
Essentia Health - Ely Clinic
RECRUITING
Ely
Essentia Health - Fosston
RECRUITING
Fosston
Essentia Health Hibbing Clinic
RECRUITING
Hibbing
Essentia Health - International Falls Clinic
RECRUITING
International Falls
Essentia Health - Moose Lake Clinic
RECRUITING
Moose Lake
Essentia Health - Park Rapids
RECRUITING
Park Rapids
Essentia Health - Saint Joseph's Pequot Lakes Clinic
RECRUITING
Pequot Lakes
Essentia Health - Saint Joseph's Pine River Clinic
RECRUITING
Pine River
Essentia Health Sandstone
RECRUITING
Sandstone
Essentia Health - Saint Joseph's Staples Clinic
RECRUITING
Staples
Essentia Health Virginia Clinic
RECRUITING
Virginia
Missouri
Parkland Health Center - Farmington
RECRUITING
Farmington
Sainte Genevieve County Memorial Hospital
RECRUITING
Sainte Genevieve
Missouri Baptist Medical Center
RECRUITING
St Louis
Missouri Baptist Sullivan Hospital
RECRUITING
Sullivan
BJC Outpatient Center at Sunset Hills
RECRUITING
Sunset Hills
North Dakota
Essentia Health Cancer Center-South University Clinic
RECRUITING
Fargo
Essentia Health - Jamestown Clinic
RECRUITING
Jamestown
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New Jersey
Saint Barnabas Medical Center
RECRUITING
Livingston
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
New Mexico
University of New Mexico Cancer Center
RECRUITING
Albuquerque
Ohio
University of Cincinnati Cancer Center-UC Medical Center
RECRUITING
Cincinnati
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
University of Cincinnati Cancer Center-West Chester
RECRUITING
West Chester
Pennsylvania
Saint Luke's Cancer Center - Allentown
RECRUITING
Allentown
Saint Luke's University Hospital-Bethlehem Campus
RECRUITING
Bethlehem
Christiana Care Health System-Concord Health Center
RECRUITING
Chadds Ford
Saint Luke's Hospital-Anderson Campus
RECRUITING
Easton
Saint Luke's Hospital - Upper Bucks Campus
RECRUITING
Quakertown
Saint Luke's Hospital - Monroe Campus
RECRUITING
Stroudsburg
Geisinger Wyoming Valley/Henry Cancer Center
RECRUITING
Wilkes-barre
Tennessee
Baptist Memorial Hospital and Cancer Center-Memphis
RECRUITING
Memphis
Virginia
VCU Massey Cancer Center at Stony Point
RECRUITING
Richmond
VCU Massey Comprehensive Cancer Center
RECRUITING
Richmond
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
University of Washington Medical Center - Montlake
RECRUITING
Seattle
Wisconsin
Duluth Clinic Ashland
RECRUITING
Ashland
Northwest Wisconsin Cancer Center
RECRUITING
Ashland
Essentia Health-Hayward Clinic
RECRUITING
Hayward
Tamarack Health Hayward Medical Center
RECRUITING
Hayward
Marshfield Medical Center-Marshfield
RECRUITING
Marshfield
ProHealth D N Greenwald Center
RECRUITING
Mukwonago
ProHealth Oconomowoc Memorial Hospital
RECRUITING
Oconomowoc
Essentia Health-Spooner Clinic
RECRUITING
Spooner
Essentia Health Saint Mary's Hospital - Superior
RECRUITING
Superior
ProHealth Waukesha Memorial Hospital
RECRUITING
Waukesha
UW Cancer Center at ProHealth Care
RECRUITING
Waukesha
Contact Information
Primary
Andrea Garcia
agarcia@swog.org
210-614-8808
Backup
Dana Sparks
dsparks@swog.org
210-614-8808
Time Frame
Start Date: 2025-05-09
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 274
Treatments
Experimental: Arm I (lanreotide, distal pancreatectomy)
Patients receive lanreotide 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.
Placebo_comparator: Arm II (saline placebo, distal pancreatectomy)
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.
Sponsors
Leads: SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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