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

Gastric Cancer and Oligometastatic Liverinvolvement. Metastatectomy and Impact on Survival

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06627634

Acronym

LEVECA

Enrollment

Registered

2024-10-04

Start date

2020-12-01

Completion date

2024-12-01

Last updated

2024-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Survival

Brief summary

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.

Interventions

PROCEDUREMetastatectomia 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Survival	2 years	Overall survival

Countries

Denmark

Contacts

Primary ContactJulie Lykke Harbjerg, MD

Juharb@rm.dk+4520404424

Backup ContactDaniel Willy Kjaer, MD, PhD

dankja@rm.dk+4551888088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026