Radical Surgery for Advanced Gastric- or GEJ-cancer With Oligometastatic Dissmination to the Liver (LEVECA)

October 3, 2024 updated by: Julie Lykke Harbjerg, Aarhus University Hospital

Gastric Cancer and Oligometastatic Liverinvolvement. Metastatectomy and Impact on Survival

Offering treatment with potential to cure for participants with no such offer in today's standard treatment options, by offering metastatectomia and standard treatment with intention to cure i.e., neoadjuvant chemotherapy and gastrectomy for participants with gastric- og gastroeusofageal junction cancer. Including 20 participants from all 4 centres in Denmark able to perform the surgical procedures in question.

Endpoints: 2-year overall survival.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

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: Julie Lykke Harbjerg, MD
  • Phone Number: +4520404424
  • Email: Juharb@rm.dk

Study Contact Backup

  • Name: Daniel Willy Kjaer, MD, PhD
  • Phone Number: +4551888088
  • Email: dankja@rm.dk

Study Locations

  • Denmark
    • Jylland
      • Aarhus, Jylland, Denmark, 8200
        • Recruiting
        • Aarhus Univercity hospital
        • Contact:
          • Julie Lykke Harbjerg
          • Phone Number: +4520404424
          • Email: Juharb@rm.dk

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 18.
  • Presence of primary T1-T4N0-N3M1 adenocarcinoma of the stomach or GEJ and max. 30% liver involvement.
  • Primary tumour resectable, based on imaging workup.
  • Surgical operable patients with ASA-score36 ≤ III and WHO performance status37 0-1.
  • Patients eligible for treatment with systemic chemotherapy by FLOT regimen.
  • Informed consent is obtained.

Exclusion Criteria:

  • Patient with non-resectable cancer.
  • Direct growth involving adjacent organs, i.e., pancreas, colon, blood vessels or bones.
  • Other malignant disease diagnosed or treated up to 2 years prior to inclusion, except non-aggressive cancers such as non-melanoma sin cancer.
  • Altered anatomy of the upper gastrointestinal tract due to previous surgery of the oesophagus, stomach, and duodenum.
  • BMI ≤ 18
  • The patient is unable to understand and/or read the consent form.
  • Other serious illness or acute infections.
  • Pregnant or breastfeeding.

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment arm
Patients with oligometastatic spread form gastric og GEJ-cancer are offered standart curative treatment along with metastatectomia in the liver.
Procedure: Metastatectomia and standard treatment for resectable disease.
Rather than palliative chemotherapy, the intervention offered to participants is preoperative chemotherapy, resection of primary tumour and metastatectomia of oligometastatic spread to the liver. If fit for post-operative chemotherapy, this is offered as well.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 2 years
Overall survival
2 years

Collaborators and Investigators

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

Sponsor

Aarhus University Hospital

Collaborators

Odense University Hospital
Rigshospitalet, Denmark
Aalborg University Hospital

Investigators

  • Study Director: Daniel Willy Kjaer, MD, PhD, Aarhus University Hospital

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 Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 1-10-72-233-20

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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