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

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

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).

Study Overview

• Status: Unknown
• Conditions: Adenocarcinomas of the Pancreas
• Intervention / Treatment: Drug: Gemcitabine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Recruiting
      • University Hospital
      • Contact: Stefan Beckert, Prof. Dr.; Phone Number: +49-7071-2981222; Email: stefan.beckert@med.uni-tuebingen.de
      • Contact: Alfred Königsrainer, Prof. Dr.; Phone Number: +49-7071-2986619; Email: alfred.koenigsrainer@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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; Other Names: Gemzar

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Stefan Beckert, Prof. Dr., University Department of General, Visceral and TransplantSurgery Tuebingen

Publications and helpful links

General Publications

• Yurttas C, Horvath P, Fischer I, Meisner C, Nadalin S, Königsrainer I, Königsrainer A, Beckert S, Löffler 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: August 8, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 11, 2016

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 30, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Gemcitabine; Adenocarcinoma; Pancreas; Hyperthermic intraperitoneal chemotherapy; HIPEC; Pancreatic surgery
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Adenocarcinoma; Hyperthermia; Fever; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine
• Other Study ID Numbers: PanHIPEC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No