Clinical trialPhase 1 / Phase 2Unknown
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)
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Unknown
- Study type
- Interventional
- Start
- January 2016
- Expected end
- October 2018
- Enrollment
- 16 participants
- Sites
- 1
- Primary outcomes
- 30 days mortality after macroscopically complete Resection ( R0 / R1 ) of an adenocarcinoma of the pancreas in combined with hyperthermic intraperitoneal chemotherapy (HIPEC)
- Sponsor
- Other
- Results posted
- No
- Last update
- 31 October 2017
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.