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

Launched by AARHUS UNIVERSITY HOSPITAL · Oct 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced stomach or gastroesophageal junction (GEJ) cancer that has spread to the liver but is still considered manageable. The goal is to potentially cure the cancer by combining a specialized surgery called metastatectomia (which removes the cancer spread in the liver) with standard treatments like chemotherapy and surgery to remove the primary tumor. The trial aims to include 20 participants from four centers in Denmark, and it's focused on improving survival rates over a two-year period.

To be eligible for this trial, participants must be at least 18 years old and have specific types of stomach or GEJ cancer that can still be surgically removed, with limited involvement of the liver. They should also be in good health overall, as assessed by their doctors. Participants can expect to receive comprehensive care, including chemotherapy before and after surgery, with the hope of achieving better outcomes than currently available treatments. It’s important to note that those with certain other health conditions or previous cancers, as well as pregnant or breastfeeding individuals, cannot join the trial.

Gender

ALL

Eligibility criteria

• 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.