Study on Hyperthermic Intraperitoneal Chemotherapy After Resection of Pancreascarcinoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adenocarcinomas of the Pancreas

Intervention / Treatment
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* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years Computertomographic (CT) morphologically suspected pancreatic tumor without distant metastases, with the possibility of a macroscopically complete resection residual tumor classification (R) R0 / R1 . Histological diagnosis of adenocarcinoma of the pancreas' in the frozen section intraoperatively Karnofsky Index > 70 Exclusion Criteria: Patients who are considered inoperable because of reduced general Congestive heart failure New York Heart Association (NYHA) III / IV Severe coronary heart disease, non-treatable arrhythmia or nonadjustable hypertension, Severe asthma suffering, chronic obstructive pulmonary disease (COPD) Renal insufficiency (serum creatinine ≥ 1.5 x of normal, or creatinine clearance <60 milliliter (ml) / minutes (min)) Patients where the intra-operative frozen section no adenocarcinoma of the pancreas can be demonstrated Patients suffering from a second malignancy (within 5 years in the study of consent) except basal cell carcinoma and curative treated insitu carcinoma of the cervix Distant metastases (M) > 0 Patients with a contraindication related to the present study Allergy or intolerance to the study drug or a substance with chemical similarity to the study medication. Patients under legal custodianship or incarcerated patients Patients that can not understand the purpose of the study due to mental, intellectual or linguistic problem Participation in Clinical Trials or other observation period of competing trials. Pregnancy, lactation Females of childbearing potential (FCBP) that do not agree To utilize two reliable forms of contraception or practice complete abstinence from Simultaneously heterosexual contact for at least 28 days before start of treatment and for at least 28 days after administration of study treatment To abstain from breastfeeding during study participation and 6 months after study treatment. Males that do not agree to use a latex condom during any sexual contact with FCBP during participation in the study and for at least 28 days study following treatment, even if he has undergone a successful vasectomy to refrain from donating semen or sperm for at least 28 days after study treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine<br>1000 milligram (mg)/ square meter (m²) body surface, intraperitoneal use, unique intraoperative application for 60 minutes | Drug: Gemcitabine<br>* 1000 milligram (mg)/square meters (m2) body surface 60 minutes (min) intraperitoneal hyperthermic lavage<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 days mortality after macroscopically complete Resection ( R0 / R1 ) of an adenocarcinoma of the pancreas in combined with hyperthermic intraperitoneal chemotherapy (HIPEC) | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 | 
| Vomiting | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 | 
| Diarrhea | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 | 
| Stomatitis | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 | 
| Hair loss | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 | 
| Neutrophilia | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 | 
| Thrombocytopenia | Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreas, Adenocarcinoma, Hyperthermic intraperitoneal chemotherapy, HIPEC, Pancreatic surgery, Gemcitabine