Study On Hyperthermic Intraperitoneal Chemotherapy After Resection Of Pancreascarcinoma

Study Overview

Study on Hyperthermic Intraperitoneal Chemotherapy After Resection of Pancreascarcinoma

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.

Adenocarcinomas of the Pancreas

DRUG: Gemcitabine

PanHIPEC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-08-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-10-30
First Submitted that Met QC Criteria 2016-08-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-10-31
First Posted (ACTUAL) 2016-08-11	Results First Posted N/A	Last Verified 2017-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Gemcitabine 1000 milligram (mg)/ square meter (m²) body surface, intraperitoneal use, unique intraoperative application for 60 minutes	DRUG: Gemcitabine 1000 milligram (mg)/square meters (m2) body surface 60 minutes (min) intraperitoneal hyperthermic lavage

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Gemcitabine

1000 milligram (mg)/ square meter (m²) body surface, intraperitoneal use, unique intraoperative application for 60 minutes

DRUG: Gemcitabine

1000 milligram (mg)/square meters (m2) body surface 60 minutes (min) intraperitoneal hyperthermic lavage

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Stefan Beckert, Prof. Dr.

Phone Number: +49-7071-2981222

Email: stefan.beckert@med.uni-tuebingen.de

Study Contact Backup

Name: Alfred Königsrainer, Prof. Dr.

Phone Number: +49-7071-2986619

Email: alfred.koenigsrainer@med.uni-tuebingen.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

≥ 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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Stefan Beckert, Prof. Dr., University Department of General, Visceral and TransplantSurgery Tuebingen

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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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