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Trial Title:
Radical Surgery for Advanced Gastric- or GEJ-cancer With Oligometastatic Dissmination to the Liver
NCT ID:
NCT06627634
Condition:
Survival
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Metastatectomia and standard treatment for resectable disease.
Description:
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.
Arm group label:
Treatment arm
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aarhus Univercity hospital
Address:
City:
Aarhus
Zip:
8200
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Julie Lykke Harbjerg
Phone:
+4520404424
Email:
Juharb@rm.dk
Start date:
December 1, 2020
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Collaborator:
Agency:
Aalborg University Hospital
Agency class:
Other
Collaborator:
Agency:
Odense University Hospital
Agency class:
Other
Source:
Aarhus University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06627634
