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

NCT06627634 | Recruiting

• 1 other identifier: 1-10-72-233-20
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Survival

Outcome Measures

Primary Outcomes (1)

• Survival

  Overall survival

  2 years

Study Arms (1)

Treatment arm

EXPERIMENTAL

Patients with oligometastatic spread form gastric og GEJ-cancer are offered standart curative treatment along with metastatectomia in the liver.

Procedure: Metastatectomia and standard treatment for resectable disease.

Interventions

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.

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient with non-resectable cancer.
• Direct growth involving adjacent organs, i.e., pancreas, colon, blood vessels or bones.
• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Aalborg University Hospital: collaborator
• Odense University Hospital: collaborator

Study Sites (1)

Aarhus Univercity hospital

Aarhus, Jylland, 8200, Denmark

RECRUITING

Study Officials

• Daniel Willy Kjaer, MD, PhD

  Aarhus University Hospital

  STUDY DIRECTOR

Central Study Contacts

Julie Lykke Harbjerg, MD

CONTACT

+4520404424; Juharb@rm.dk

Daniel Willy Kjaer, MD, PhD

CONTACT

+4551888088; dankja@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: October 4, 2024
• Study Start: December 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)