A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula
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.
Detailed description
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.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo blood sample and pancreas fluid collection
- ProcedureDistal Pancreatectomy
Undergo distal pancreatectomy
- DrugLanreotide
Given SC
- OtherQuestionnaire Administration
Ancillary studies
- OtherSaline
Given SC
Outcome measures
Primary
Incidence of postoperative pancreatic fistula (POPF)
POPF will be assessed using the 2016 International Study Group for Pancreas Surgery (ISGPS). Incidence rates of POPF in each treatment arm will be described, and treatment arm differences assessed via logistic regression model with adjustment for stratification factor.
Time frame: Up to 60 days after distal pancreatectomy
Secondary
Incidence of biochemical leak (BL)
Time frame: Up to 60 days after distal pancreatectomy
Number of post-operation hospital days
Time frame: From the time of surgery up to 60 days after distal pancreatectomy
Change in overall quality of life (QOL)
Time frame: At baseline and at 14 and 60 days after surgery
Eligibility criteria
Study locations (118)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, Alabama, 36526
Thomas Hospital
Fairhope, Alabama, 36532
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Saraland, Alabama, 36571
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California, 92357
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801
Moffitt Cancer Center at SouthShore
Ruskin, Florida, 33570
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
Moffitt Cancer Center
Tampa, Florida, 33612
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, 33544
Grady Health System
Atlanta, Georgia, 30303
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
Northwestern University
Chicago, Illinois, 60611
University of Illinois
Chicago, Illinois, 60612
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Christiana Care - Union Hospital
Elkton, Maryland, 21921
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Bronson Battle Creek
Battle Creek, Michigan, 49017
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
University of Michigan Health - West
Wyoming, Michigan, 49519
Riverwood Healthcare Center
Aitkin, Minnesota, 56431
Essentia Health - Baxter Clinic
Baxter, Minnesota, 56425
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Essentia Health - Saint Joseph's Crosslake Clinic
Crosslake, Minnesota, 56442
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Essentia Health - Ely Clinic
Ely, Minnesota, 55731
Essentia Health - Fosston
Fosston, Minnesota, 56542
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Essentia Health - International Falls Clinic
International Falls, Minnesota, 56649
Essentia Health - Moose Lake Clinic
Moose Lake, Minnesota, 55767
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470
Essentia Health - Saint Joseph's Pequot Lakes Clinic
Pequot Lakes, Minnesota, 56472
Essentia Health - Saint Joseph's Pine River Clinic
Pine River, Minnesota, 56474
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Essentia Health - Saint Joseph's Staples Clinic
Staples, Minnesota, 56479
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Renown Regional Medical Center
Reno, Nevada, 89502
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
University of Rochester
Rochester, New York, 14642
State University of New York Upstate Medical University
Syracuse, New York, 13210
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, 58401
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
Saint Luke's Cancer Center - Allentown
Allentown, Pennsylvania, 18104
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Saint Luke's Hospital-Anderson Campus
Easton, Pennsylvania, 18045
Saint Luke's Hospital - Upper Bucks Campus
Quakertown, Pennsylvania, 18951
Saint Luke's Hospital - Monroe Campus
Stroudsburg, Pennsylvania, 18360
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
University of Vermont Medical Center
Burlington, Vermont, 05401
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24033
Valley Health / Winchester Medical Center
Winchester, Virginia, 22601
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843
Tamarack Health Hayward Medical Center
Hayward, Wisconsin, 54843
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188