Spots Global Cancer Trial Database for Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC
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Trial Identification
Brief Title: Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC
Official Title: Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following Induction With Sequential IV Gemcitabine Plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer
Study ID: NCT03257033
Conditions
Study Description
Brief Summary: The study is a multi-center, un-blinded, randomized control study of subjects with locally advanced pancreatic adenocarcinoma which is unresectable.
Detailed Description: All subjects will receive induction therapy of IV gemcitabine plus nab-paclitaxel, as well as radiation therapy for approximately four months. Subjects who remain eligible will then be randomized to receive either intra-arterial chemotherapy with gemcitabine; or to continue gemcitabine plus nab-paclitaxel. Subjects will receive the randomized treatments for up to 16 weeks or until progression. Both groups will receive either IV gemcitabine and nab-paclitaxel or oral capecitabine following the 16 week treatment course until disease progression at the discretion of the Investigator.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
VA Loma Linda Healthcare System, Loma Linda, California, United States
Sutter Cancer Center Sacramento, Sacramento, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Comprehensive Cancer Care and Research Institute of Colorado, CCCRIC, Englewood, Colorado, United States
Georgetown University, Washington, District of Columbia, United States
21st Century Oncology, Fort Myers, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
Sarasota Memorial Health Care System, Sarasota, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
ASCLEPES Research Centers, Weeki Wachee, Florida, United States
Piedmont-Columbus Regional - John B. Amos Cancer Center, Columbus, Georgia, United States
University of Iowa Hospitals and Clinics - Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
LSU Health Shreveport, Shreveport, Louisiana, United States
Medstar Franklin Square, Baltimore, Maryland, United States
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
MD Anderson Cancer Center at Cooper Hospital, Camden, New Jersey, United States
Atlantic Health System - Morristown Medical Center, Morristown, New Jersey, United States
Albany Stratton VA Medical Center, Albany, New York, United States
Montefiore Hospital, Bronx, New York, United States
Columbia University Medical Center, New York, New York, United States
Levine Cancer Institute - Atrium Health, Charlotte, North Carolina, United States
East Carolina University, Greenville, North Carolina, United States
Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Oklahoma University - Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Oregon Health & Science University, Portland, Oregon, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina - Hollings Cancer Center, Charleston, South Carolina, United States
Prisma Health (formerly Greenville Health System), Greenville, South Carolina, United States
VA Puget Sound Health Care System, Seattle, Washington, United States
West Virginia University Medicine, Morgantown, West Virginia, United States
AZ Sint-Lucas, Brugge, , Belgium
UZ Antwerp, Edegem, , Belgium
AZ Maria Middelares, Gent, , Belgium
UZ Gent, Gent, , Belgium
Jolimont Hospital, La Louvière, , Belgium
AZ Delta, Roeselare, , Belgium
Contact Details
Name: Michael J Pishvaian
Affiliation: Johns Hopkins Kimmel Cancer Center
Role: STUDY_CHAIR
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