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Recruiting

NCT Number: NCT06627634

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

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.

Recruiting

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Key information

Conditions

Survival

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus Univercity hospital

Aarhus, Jylland, 8200, Denmark

Location status: Recruiting

Location contact

Julie Lykke Harbjerg

CONTACT

[email protected]

+4520404424

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metastatectomia and standard treatment for resectable disease.

Procedure

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.

Primary outcomes

  1. Survival

    Time frame: 2 years

    Overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Willy Kjaer, MD, PhD

CONTACT

[email protected]

+4551888088

Julie Lykke Harbjerg, MD

CONTACT

[email protected]

+4520404424

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Aalborg University Hospital
  • Odense University Hospital
  • Rigshospitalet, Denmark

Registry information

Official study title

Gastric Cancer and Oligometastatic Liverinvolvement. Metastatectomy and Impact on Survival

Acronym: LEVECA

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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