Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06807437

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

Led by SWOG Cancer Research Network · Updated on 2026-03-31

274

Participants Needed

118

Research Sites

129 weeks

Total Duration

On this page

Sponsors

S

SWOG Cancer Research Network

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 118 locations

1

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States, 35233

Suspended

2

Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis

Daphne, Alabama, United States, 36526

Suspended

3

Thomas Hospital

Fairhope, Alabama, United States, 36532

Suspended

4

Mobile Infirmary Medical Center

Mobile, Alabama, United States, 36607

Suspended

5

Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland

Saraland, Alabama, United States, 36571

Suspended

6

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

Suspended

7

City of Hope Comprehensive Cancer Center

Duarte, California, United States, 91010

Suspended

8

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92093

Actively Recruiting

9

Veterans Affairs Loma Linda Healthcare System

Loma Linda, California, United States, 92357

Suspended

10

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Suspended

11

UC San Diego Medical Center - Hillcrest

San Diego, California, United States, 92103

Suspended

12

Helen F Graham Cancer Center

Newark, Delaware, United States, 19713

Suspended

13

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States, 19713

Suspended

14

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States, 19718

Suspended

15

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States, 19801

Suspended

16

Moffitt Cancer Center at SouthShore

Ruskin, Florida, United States, 33570

Suspended

17

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States, 33607

Suspended

18

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States, 33612

Actively Recruiting

19

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Suspended

20

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, United States, 33544

Suspended

21

Grady Health System

Atlanta, Georgia, United States, 30303

Suspended

22

Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

Suspended

23

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Suspended

24

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States, 30342

Suspended

25

Emory Johns Creek Hospital

Johns Creek, Georgia, United States, 30097

Suspended

26

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

27

University of Illinois

Chicago, Illinois, United States, 60612

Actively Recruiting

28

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States, 60134

Suspended

29

Northwestern Medicine Oak Brook

Oak Brook, Illinois, United States, 60523

Suspended

30

Northwestern Medicine Orland Park

Orland Park, Illinois, United States, 60462

Suspended

31

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States, 60555

Suspended

32

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States, 46202

Suspended

33

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States, 40536

Actively Recruiting

34

University Medical Center New Orleans

New Orleans, Louisiana, United States, 70112

Suspended

35

Christiana Care - Union Hospital

Elkton, Maryland, United States, 21921

Suspended

36

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States, 48109

Suspended

37

Bronson Battle Creek

Battle Creek, Michigan, United States, 49017

Suspended

38

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States, 49503

Suspended

39

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

Grand Rapids, Michigan, United States, 49503

Suspended

40

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States, 49503

Suspended

41

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States, 49444

Suspended

42

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, United States, 49120

Suspended

43

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, United States, 49444

Suspended

44

Corewell Health Reed City Hospital

Reed City, Michigan, United States, 49677

Suspended

45

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, United States, 49085

Suspended

46

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, United States, 49085

Suspended

47

University of Michigan Health - West

Wyoming, Michigan, United States, 49519

Suspended

48

Riverwood Healthcare Center

Aitkin, Minnesota, United States, 56431

Suspended

49

Essentia Health - Baxter Clinic

Baxter, Minnesota, United States, 56425

Suspended

50

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, United States, 56401

Suspended

51

Essentia Health - Saint Joseph's Crosslake Clinic

Crosslake, Minnesota, United States, 56442

Suspended

52

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States, 56636

Suspended

53

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota, United States, 56501

Suspended

54

Essentia Health Cancer Center

Duluth, Minnesota, United States, 55805

Suspended

55

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, United States, 55805

Suspended

56

Miller-Dwan Hospital

Duluth, Minnesota, United States, 55805

Suspended

57

Essentia Health - Ely Clinic

Ely, Minnesota, United States, 55731

Suspended

58

Essentia Health - Fosston

Fosston, Minnesota, United States, 56542

Suspended

59

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States, 55746

Suspended

60

Essentia Health - International Falls Clinic

International Falls, Minnesota, United States, 56649

Suspended

61

Essentia Health - Moose Lake Clinic

Moose Lake, Minnesota, United States, 55767

Suspended

62

Essentia Health - Park Rapids

Park Rapids, Minnesota, United States, 56470

Suspended

63

Essentia Health - Saint Joseph's Pequot Lakes Clinic

Pequot Lakes, Minnesota, United States, 56472

Suspended

64

Essentia Health - Saint Joseph's Pine River Clinic

Pine River, Minnesota, United States, 56474

Suspended

65

Essentia Health Sandstone

Sandstone, Minnesota, United States, 55072

Suspended

66

Essentia Health - Saint Joseph's Staples Clinic

Staples, Minnesota, United States, 56479

Suspended

67

Essentia Health Virginia Clinic

Virginia, Minnesota, United States, 55792

Suspended

68

Parkland Health Center - Farmington

Farmington, Missouri, United States, 63640

Actively Recruiting

69

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States, 63670

Actively Recruiting

70

Missouri Baptist Medical Center

St Louis, Missouri, United States, 63131

Actively Recruiting

71

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States, 63080

Actively Recruiting

72

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States, 63127

Actively Recruiting

73

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Suspended

74

Renown Regional Medical Center

Reno, Nevada, United States, 89502

Suspended

75

Saint Barnabas Medical Center

Livingston, New Jersey, United States, 07039

Suspended

76

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08903

Suspended

77

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States, 87106

Suspended

78

University of Rochester

Rochester, New York, United States, 14642

Suspended

79

State University of New York Upstate Medical University

Syracuse, New York, United States, 13210

Suspended

80

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States, 28203

Suspended

81

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, United States, 28025

Suspended

82

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, United States, 58103

Suspended

83

Sanford Broadway Medical Center

Fargo, North Dakota, United States, 58122

Suspended

84

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States, 58122

Suspended

85

Essentia Health - Jamestown Clinic

Jamestown, North Dakota, United States, 58401

Suspended

86

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States, 45219

Suspended

87

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Suspended

88

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States, 45069

Suspended

89

Saint Luke's Cancer Center - Allentown

Allentown, Pennsylvania, United States, 18104

Actively Recruiting

90

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, United States, 18015

Actively Recruiting

91

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, United States, 19317

Suspended

92

Saint Luke's Hospital-Anderson Campus

Easton, Pennsylvania, United States, 18045

Actively Recruiting

93

Saint Luke's Hospital - Upper Bucks Campus

Quakertown, Pennsylvania, United States, 18951

Actively Recruiting

94

Saint Luke's Hospital - Monroe Campus

Stroudsburg, Pennsylvania, United States, 18360

Actively Recruiting

95

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States, 18711

Suspended

96

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States, 57104

Suspended

97

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States, 57117-5134

Suspended

98

University of Tennessee - Knoxville

Knoxville, Tennessee, United States, 37920

Suspended

99

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, United States, 38120

Suspended

100

University of Vermont Medical Center

Burlington, Vermont, United States, 05401

Suspended

101

University of Vermont and State Agricultural College

Burlington, Vermont, United States, 05405

Suspended

102

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States, 23235

Actively Recruiting

103

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States, 23298

Actively Recruiting

104

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States, 24033

Suspended

105

Valley Health / Winchester Medical Center

Winchester, Virginia, United States, 22601

Suspended

106

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Suspended

107

University of Washington Medical Center - Montlake

Seattle, Washington, United States, 98195

Suspended

108

Duluth Clinic Ashland

Ashland, Wisconsin, United States, 54806

Suspended

109

Northwest Wisconsin Cancer Center

Ashland, Wisconsin, United States, 54806

Suspended

110

Essentia Health-Hayward Clinic

Hayward, Wisconsin, United States, 54843

Suspended

111

Tamarack Health Hayward Medical Center

Hayward, Wisconsin, United States, 54843

Suspended

112

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States, 54449

Actively Recruiting

113

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States, 53149

Suspended

114

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States, 53066

Suspended

115

Essentia Health-Spooner Clinic

Spooner, Wisconsin, United States, 54801

Suspended

116

Essentia Health Saint Mary's Hospital - Superior

Superior, Wisconsin, United States, 54880

Suspended

117

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, United States, 53188

Suspended

118

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States, 53188

Suspended

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Research Team

A

Andrea Garcia

CONTACT

D

Dana Sparks

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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