Spots Global Cancer Trial Database for Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma
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Trial Identification
Brief Title: Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma
Official Title: A Phase 2 Study of Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma
Study ID: NCT01206296
Conditions
Interventions
Study Description
Brief Summary: This is a phase II study evaluating the use of intraperitoneal gemcitabine given intraoperatively and as adjuvant therapy for patients with resectable pancreas cancer. The primary objective of this study is to evaluate the overall safety of intraperitoneal gemcitabine given intraoperatively and postoperatively for adjuvant treatment of resectable pancreatic adenocarcinoma. The secondary objectives are to evaluate the efficacy of this treatment regimen as reflected in overall survival at 2-years, to study the patterns of disease recurrence following this treatment, to study the pharmacology of intraperitoneal gemcitabine and to study changes in peritoneal cytology with pancreatic cancer resection.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Washington Cancer Institute at MedStar Washington Hospital Center, Washington, District of Columbia, United States
Contact Details
Name: Lana Bijelic, MD
Affiliation: Medstar Health Research Institute
Role: PRINCIPAL_INVESTIGATOR
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