NCT02863471

Study on Hyperthermic Intraperitoneal Chemotherapy After Resection of Pancreascarcinoma

Open-label Pilot Phase I / II Study on Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Macroscopically Complete Resection (R0/R1) of Adenocarcinomas of the Pancreas (PanHIPEC)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

In patients with peritoneal metastases of colorectal cancer could be a radical removal of all tumor foci a significantly improved survival compared to a sole systemic chemotherapy are additionally achieved by a hyperthermic intraoperative chemotherapy (HIPEC).

Detailed description

Despite medical progress in recent years in pancreatic reach the 5-year survival rates even after radical surgical resection only 20%, which is due to high rates of local recurrence and distant metastases in the postoperative course. Due to the anatomical position of the pancreas resections are having a "wide margin" technically almost impossible, so that the tumor on postoperative preparation is often marginal forming. A further possible explanation for the high number of local recurrences, intraoperative tumor cell displacement in question. In patients with peritoneal metastases of colorectal cancer could be a radical removal of all tumor foci a significantly improved survival compared to a sole systemic chemotherapy are additionally achieved by a hyperthermic intraoperative chemotherapy (HIPEC). Purpose of HIPEC it is to kill any remaining microscopic residual tumor or residual tumor cells free. The aim of the present phase I / II study is therefore to examine the importance of HIPEC in addition to radical resection of ductal pancreatic cancer in terms of mortality and morbidity.

Conditions

• Adenocarcinomas of the Pancreas

Interventions

Type	Name	Description
DRUG	Gemcitabine	1000 milligram (mg)/square meters (m2) body surface 60 minutes (min) intraperitoneal hyperthermic lavage

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-07-01
• Completion: 2018-10-01
• First posted: 2016-08-11
• Last updated: 2017-10-31

Locations

1 site across 1 country: Germany