Health TrialsbyHealthPanel

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

ConditionSurvival
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAarhus University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Metastatectomia and standard treatment for resectable disease.

    Procedure/Surgery

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Treatment armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Survival

Overall survival

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aarhus University Hospital

Lead sponsor

Rigshospitalet, Denmark

Collaborator

Aalborg University Hospital

Collaborator

Odense University Hospital

Collaborator

Source ClinicalTrials.gov
Apply now