Radical Surgery for Advanced Gastric- or GEJ-cancer With Oligometastatic Dissmination to the Liver
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metastatectomia and standard treatment for resectable disease..
- Who it may be relevant to
- Registry conditions: Survival. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Gastric Cancer and Oligometastatic Liverinvolvement. Metastatectomy and Impact on Survival
Overview
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
- 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.
Primary outcome measures
- Survival [Time frame: 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Aarhus Univercity hospital — Aarhus
Identifiers
NCT: NCT06627634 · 1-10-72-233-20