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

NCT ID: NCT06627634

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2024-12-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

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

Group Type: EXPERIMENTAL

Metastatectomia and standard treatment for resectable disease.

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Julie Lykke Harbjerg

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Willy Kjaer, MD, PhD

Role: STUDY_DIRECTOR

Aarhus University Hospital

Locations

Aarhus Univercity hospital

Aarhus, Jylland, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Julie Lykke Harbjerg, MD

Role: CONTACT

Juharb@rm.dk

+4520404424

Daniel Willy Kjaer, MD, PhD

Role: CONTACT

dankja@rm.dk

+4551888088

Facility Contacts

Julie Lykke Harbjerg

Role: primary

Juharb@rm.dk

+4520404424

Other Identifiers

1-10-72-233-20

Identifier Type: -

Identifier Source: org_study_id