Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Oslo University Hospital
With
Norwegian Cancer Society
The Research Council of Norway
Klinbeforsk
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
First time CRCLM (synchronous or metachronous).
Recurrence of CRCLM (not previously included in this trial).
In synchronous CRCLM and "Liver first" approach, the primary tumor must be resected within 6 weeks after the liver
Macroscopic (surgical) free resection margins (R0 or R1 resection).
Must be ambulatory with a performance status Eastern Cooperative Oncology Group (ECOG) 0-2.
Must be at least 18 years of age.
Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonization - Good Clinical Practice (ICH GCP), and national/local regulations.
You may not be if
Concomitant use of ASA or other anticoagulants or platelet inhibitors such as warfarin or clopidogrel.
Ongoing regular use of corticosteroids or NSAIDs.
Inherited or acquired coagulopathy (haemophilia).
Blood platelets (thrombocytes) \< 100 x 10\^9/L.
Severe heart failure (classified as New York Heart Association (NYHA) class \>III)
Severe kidney failure \>Stage 3b
CRCLM previously treated with radiofrequency or microwave ablation technique
Pregnancy or breastfeeding. For women in childbearing age there will be pregnancy test at monthly intervals (urine human chorionic gonadotropin (HCG) pregnancy tests (for home testing) will be given to the patients for monthly tests and the patient will self-report the results at each control). Furthermore, highly effective contraceptives will be required.
Childbearing potential without proper contraceptive measures such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device to avoid pregnancy for the entire study period.
Liver cirrhosis with a Child-Pugh score \>B7.
Alcoholism.
Contraindication listed on the Summary of Product Characteristics (SmPC) of Trombyl: Hypersensitivity/allergies to ASA, Thrombocytopenia, Previous severe gastrointestinal haemorrhage/peptic ulcer due to ASA/NSAID, Active peptic ulcer, Haemophilia, Liver cirrhosis, Severe congestive heart failure.
Need to use concomitant medications contraindicated according to SmPC of Trombyl.
