Conditions: Pancreatic Adenocarcinoma
Keywords: Adjuvant Intraperitoneal Gemcitabine Pancreas Adenocarcinoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 9
Healthy volunteers: no

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:

Arms:
arm 1: Intraperitoneal Gemcitabine

Interventions: intervention 1: Intraperitoneal Gemcitabine
Intervention descriptions: intervention 1: Standard pancreatic resection followed by heated intraoperative intraperitoneal gemcitabine 1000 mg/m2

Adjuvant intraperitoneal gemcitabine treatments (days 1, 8 and 15 of each 4-week cycle) for 6 cycles

Protocol document: