Lanreotide versus placebo before surgery to prevent a pancreatic fistula
Official title: A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula
Run by SWOG Cancer Research Network · NCT06807437 · Data updated 2026-11-12
This trial will see if giving lanreotide before a planned distal pancreatectomy lowers the risk of a pancreatic fistula in adults with pancreatic cancer or a suspicious pancreatic lesion.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 274 (estimated) |
| Sponsor | SWOG Cancer Research Network Research network |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 118 sites (Birmingham, Alabama and 117 other locations) |
| Status | Recruiting |
| Started | May 9, 2025 |
| Main results expected | April 1, 2029 |
| Study ends | April 1, 2029 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT06807437 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with histologically confirmed or radiographically suspected pancreatic cancer or a lesion with malignant potential who are scheduled for an elective distal pancreatectomy within 60 days and who have not received somatostatin analogues within 180 days or prior pancreatic radiation/PRRT are the intended participants.
✕Probably not a fit
Patients undergoing other types of pancreatic surgery (for example pancreaticoduodenectomy), those having emergency operations, or those with recent somatostatin analogue therapy, prior pancreatic radiation, PRRT, or malabsorption are unlikely to be eligible or to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized phase III trial comparing a short course of preoperative lanreotide versus placebo in adults undergoing elective distal pancreatectomy for biopsy-proven or suspected pancreatic neoplasms. Participants are randomized to receive lanreotide or saline placebo before surgery and are followed for postoperative pancreatic fistula (POPF) and other complications for 60 days. Secondary outcomes include biochemical leak rates in patients with surgical drains, length of postoperative hospital stay, and changes in cancer-specific and overall quality of life measured at 14 and 60 days. Biospecimens and standardized questionnaires are collected to support safety and quality-of-life analyses.
Why it matters
Potential benefit: If effective, preoperative lanreotide could lower the rate of postoperative pancreatic fistulas and related complications after distal pancreatectomy.
How similar studies have gone: Smaller trials and meta-analyses of somatostatin analogues have shown mixed but sometimes promising reductions in postoperative pancreatic fistula rates, while preoperative lanreotide specifically has been less extensively tested and remains under evaluation in this phase III trial.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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UC San Diego Moores Cancer Center
La Jolla, California, United States Recruiting -
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States Recruiting -
Northwestern University
Chicago, Illinois, United States Recruiting -
University of Illinois
Chicago, Illinois, United States Recruiting -
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States Recruiting -
Parkland Health Center - Farmington
Farmington, Missouri, United States Recruiting
Show 44 more locations
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Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States Recruiting -
Missouri Baptist Medical Center
St Louis, Missouri, United States Recruiting -
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States Recruiting -
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, United States Recruiting -
Saint Luke's Cancer Center - Allentown
Allentown, Pennsylvania, United States Recruiting -
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States Recruiting -
Saint Luke's Hospital-Anderson Campus
Easton, Pennsylvania, United States Recruiting -
Saint Luke's Hospital - Upper Bucks Campus
Quakertown, Pennsylvania, United States Recruiting -
Saint Luke's Hospital - Monroe Campus
Stroudsburg, Pennsylvania, United States Recruiting -
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States Recruiting -
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States Recruiting -
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States Recruiting -
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States Suspended -
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, Alabama, United States Suspended -
Thomas Hospital
Fairhope, Alabama, United States Suspended -
Mobile Infirmary Medical Center
Mobile, Alabama, United States Suspended -
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Saraland, Alabama, United States Suspended -
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States Suspended -
City of Hope Comprehensive Cancer Center
Duarte, California, United States Suspended -
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California, United States Suspended -
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States Suspended -
UC San Diego Medical Center - Hillcrest
San Diego, California, United States Suspended -
Helen F Graham Cancer Center
Newark, Delaware, United States Suspended -
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States Suspended -
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States Suspended -
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States Suspended -
Moffitt Cancer Center at SouthShore
Ruskin, Florida, United States Suspended -
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States Suspended -
Moffitt Cancer Center
Tampa, Florida, United States Suspended -
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States Suspended -
Grady Health System
Atlanta, Georgia, United States Suspended -
Emory University Hospital Midtown
Atlanta, Georgia, United States Suspended -
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States Suspended -
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States Suspended -
Emory Johns Creek Hospital
Johns Creek, Georgia, United States Suspended -
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States Suspended -
Northwestern Medicine Oak Brook
Oak Brook, Illinois, United States Suspended -
Northwestern Medicine Orland Park
Orland Park, Illinois, United States Suspended -
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States Suspended -
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States Suspended -
University Medical Center New Orleans
New Orleans, Louisiana, United States Suspended -
Christiana Care - Union Hospital
Elkton, Maryland, United States Suspended -
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States Suspended -
Bronson Battle Creek
Battle Creek, Michigan, United States Suspended
+68 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Jonathan G Sham — SWOG Cancer Research Network
- Study coordinator: Andrea Garcia
- Email: agarcia@swog.org
- Phone: 210-614-8808
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.