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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine | Experimental | 1000 milligram (mg)/ square meter (m²) body surface, intraperitoneal use, unique intraoperative application for 60 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | 1000 milligram (mg)/square meters (m2) body surface 60 minutes (min) intraperitoneal hyperthermic lavage |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
Males that do not agree
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Beckert, Prof. Dr. | Contact | +49-7071-2981222 | stefan.beckert@med.uni-tuebingen.de | |
| Alfred Königsrainer, Prof. Dr. | Contact | +49-7071-2986619 | alfred.koenigsrainer@med.uni-tuebingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Stefan Beckert, Prof. Dr. | University Department of General, Visceral and TransplantSurgery Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34131821 | Derived | Yurttas C, Horvath P, Fischer I, Meisner C, Nadalin S, Konigsrainer I, Konigsrainer A, Beckert S, Loffler MW. A Prospective, Phase I/II, Open-Label Pilot Trial to Assess the Safety of Hyperthermic Intraperitoneal Chemotherapy After Oncological Resection of Pancreatic Adenocarcinoma. Ann Surg Oncol. 2021 Dec;28(13):9086-9095. doi: 10.1245/s10434-021-10187-8. Epub 2021 Jun 15. |
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| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| 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 |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |