NCT02863471

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

2.5 years

First QC Date

August 8, 2016

Last Update Submit

October 30, 2017

Conditions

Adenocarcinomas of the Pancreas

Keywords

PancreasAdenocarcinomaHyperthermic intraperitoneal chemotherapyHIPECPancreatic surgeryGemcitabine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Nausea

    day 30

  • Vomiting

    day 30

  • Diarrhea

    day 30

  • Stomatitis

    day 30

  • Hair loss

    day 30

  • +2 more secondary outcomes

Study Arms (1)

Gemcitabine

EXPERIMENTAL

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

Drug: Gemcitabine

Interventions

GemcitabineDRUG

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

Also known as: Gemzar
Gemcitabine

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34131821DERIVED

MeSH Terms

Conditions

Adenocarcinoma

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Stefan Beckert, Prof. Dr.

    University Department of General, Visceral and TransplantSurgery Tuebingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Beckert, Prof. Dr.

CONTACT

+49-7071-2981222stefan.beckert@med.uni-tuebingen.de

Alfred Königsrainer, Prof. Dr.

CONTACT

+49-7071-2986619alfred.koenigsrainer@med.uni-tuebingen.de

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 11, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2018

Study Completion

October 1, 2018

Last Updated

October 31, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)