Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study on Hyperthermic Intraperitoneal Chemotherapy After Resection of Pancreascarcinoma (PanHIPEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02863471
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief 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).

Condition or disease Intervention/treatment Phase
Adenocarcinomas of the Pancreas Drug: Gemcitabine Phase 1 Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Pilot Phase I / II Study on Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Macroscopically Complete Resection (R0/R1) of Adenocarcinomas of the Pancreas (PanHIPEC)
Actual Study Start Date : January 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

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
Other Name: Gemzar




Primary Outcome Measures :
  1. 30 days mortality after macroscopically complete Resection ( R0 / R1 ) of an adenocarcinoma of the pancreas in combined with hyperthermic intraperitoneal chemotherapy (HIPEC) [ Time Frame: day 30 ]
    Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0


Secondary Outcome Measures :
  1. Nausea [ Time Frame: day 30 ]
    Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0

  2. Vomiting [ Time Frame: day 30 ]
    Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0

  3. Diarrhea [ Time Frame: day 30 ]
    Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0

  4. Stomatitis [ Time Frame: day 30 ]
    Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0

  5. Hair loss [ Time Frame: day 30 ]
    Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0

  6. Neutrophilia [ Time Frame: day 30 ]
    Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0

  7. Thrombocytopenia [ Time Frame: day 30 ]
    Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863471


Contacts
Layout table for location contacts
Contact: Stefan Beckert, Prof. Dr. +49-7071-2981222 stefan.beckert@med.uni-tuebingen.de
Contact: Alfred Königsrainer, Prof. Dr. +49-7071-2986619 alfred.koenigsrainer@med.uni-tuebingen.de

Locations
Layout table for location information
Germany
University Hospital Recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Contact: Stefan Beckert, Prof. Dr.    +49-7071-2981222    stefan.beckert@med.uni-tuebingen.de   
Contact: Alfred Königsrainer, Prof. Dr.    +49-7071-2986619    alfred.koenigsrainer@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Layout table for investigator information
Principal Investigator: Stefan Beckert, Prof. Dr. University Department of General, Visceral and TransplantSurgery Tuebingen

Layout table for additonal information
Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02863471     History of Changes
Other Study ID Numbers: PanHIPEC
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital Tuebingen:
Pancreas
Adenocarcinoma
Hyperthermic intraperitoneal chemotherapy
HIPEC
Pancreatic surgery
Gemcitabine

Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Fever
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Body Temperature Changes
Signs and Symptoms
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs