search
Back to results

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

Primary Purpose

Adenocarcinomas of the Pancreas

Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Gemcitabine
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinomas of the Pancreas focused on measuring Pancreas, Adenocarcinoma, Hyperthermic intraperitoneal chemotherapy, HIPEC, Pancreatic surgery, Gemcitabine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Nausea
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Vomiting
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Diarrhea
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Stomatitis
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Hair loss
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Neutrophilia
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Thrombocytopenia
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0

Full Information

First Posted
August 8, 2016
Last Updated
October 30, 2017
Sponsor
University Hospital Tuebingen
search

1. Study Identification

Unique Protocol Identification Number
NCT02863471
Brief Title
Study on Hyperthermic Intraperitoneal Chemotherapy After Resection of Pancreascarcinoma
Acronym
PanHIPEC
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (Actual)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinomas of the Pancreas
Keywords
Pancreas, Adenocarcinoma, Hyperthermic intraperitoneal chemotherapy, HIPEC, Pancreatic surgery, Gemcitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine
Arm Type
Experimental
Arm Description
1000 milligram (mg)/ square meter (m²) body surface, intraperitoneal use, unique intraoperative application for 60 minutes
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
1000 milligram (mg)/square meters (m2) body surface 60 minutes (min) intraperitoneal hyperthermic lavage
Primary Outcome Measure Information:
Title
30 days mortality after macroscopically complete Resection ( R0 / R1 ) of an adenocarcinoma of the pancreas in combined with hyperthermic intraperitoneal chemotherapy (HIPEC)
Description
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Time Frame
day 30
Secondary Outcome Measure Information:
Title
Nausea
Description
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Time Frame
day 30
Title
Vomiting
Description
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Time Frame
day 30
Title
Diarrhea
Description
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Time Frame
day 30
Title
Stomatitis
Description
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Time Frame
day 30
Title
Hair loss
Description
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Time Frame
day 30
Title
Neutrophilia
Description
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Time Frame
day 30
Title
Thrombocytopenia
Description
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Time Frame
day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Beckert, Prof. Dr.
Phone
+49-7071-2981222
Email
stefan.beckert@med.uni-tuebingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alfred Königsrainer, Prof. Dr.
Phone
+49-7071-2986619
Email
alfred.koenigsrainer@med.uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Beckert, Prof. Dr.
Organizational Affiliation
University Department of General, Visceral and TransplantSurgery Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Beckert, Prof. Dr.
Phone
+49-7071-2981222
Email
stefan.beckert@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Alfred Königsrainer, Prof. Dr.
Phone
+49-7071-2986619
Email
alfred.koenigsrainer@med.uni-tuebingen.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34131821
Citation
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.
Results Reference
derived

Learn more about this trial

Study on Hyperthermic Intraperitoneal Chemotherapy After Resection of Pancreascarcinoma

We'll reach out to this number within 24 hrs