Liver metastasis from colorectal cancer. MedDRA version: 20.0 Level: LLT Classification code 10010029 Term: Colorectal cancer NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Trombyl
Product Name: Trombyl
Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLSALICYLIC ACID
Other descriptive name: ACETYLSALICYLIC ACID
Concentration unit: mg milligram(s)
Concent
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects undergoing liver resection for CRCLM as a part of a curative intent may be included in the study if • They meet one of the following criteria: o First time CRCLM (synchronous or metachronous) o Recurrence of CRCLM (not previously included in this trial) • Histologically verified free resection margins (R0 resection or R1 (=65 years) yes F.1.3.1 Number of subjects for this age range 500
Exclusion criteria
Exclusion criteria: Concomitant use of ASA or other anticoagulants or platelet inhibitors such as warfarin or klopidogrel • Ongoing regular use of corticosteroids, NSAIDs • Inherited or acquired coagulopathy (hemophilia) • Severe heart failure (classified as NYHA class >III) or kidney failure • CRCLM treated with radiofrequency or microwave ablation technique • Pregnancy or breastfeeding (negative pregnancy test will be required when indicated) • 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 or barrier methods (diaphragm, condoms, spermicides) to avoid pregnancy for the entire study period • Liver cirrhosis with a Child-Pugh score >B7 • Contraindication listed on the Summary of Product Characteristics (SmPC) of Trombyl: • Hypersensitivity/allergies to ASA • Previous severe gastrointestinal haemorrage/peptic ulcer due to ASA/NSAID • Active peptic ulcer • Hemophilia • Need to use medications contraindicated according to SmPC of Trombyl from Medicines Agency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a multi-centre, double-blinded, randomized, placebo-controlled clinical intervention trial with acetylsalicylic acid (ASA, Trombyl) in patients undergoing liver resection for colorectal cancer liver metastasis (CRCLM). The main objective is to determine whether treatment with 160 mg ASA (Trombyl) once daily for 3 years can improve Disease Free Survival (DFS) in patients treated with resection for CRCLM, compared with placebo.;Secondary Objective: Secondary objectives are to determine the effect of Trombyl on Time to Recurrence (TTR), Overall Survival (OS), and QoL in CRCLM patients, compared with placebo. Determine if ASA can improve DFS and OS in patients with mutations in PIK3CA.;Primary end point(s): Time from randomisation to disease recurrence (by CT scan or MRI) or death by any cause (DFS).;Timepoint(s) of evaluation of this end point: All included patients will be monitored with CT-scan of the chest and abdomen every 4 months for 1 year and further every 6 months till end of study period ( total three years). This is in-line with the Norwegian National Guidelines for follow-up of patients operated for CRC liver metastases. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints - Time from randomisation to disease recurrence (TTR) - Time from randomisation to death by any cause (OS) HRQOL outcome measures: - SF36 - EQ-5D health surveys;Timepoint(s) of evaluation of this end point: All included patients will be monitored with CT-scan of the chest and abdomen every 4 months for 1 year and further every 6 months till end of study period ( total three years). Health-related QoL surveys (SF36 and EQ-D5) will be filled out by the patient at every clinical control, which is every 4 months for 1 year and further every 6 months till end of study period ( total three years). Time of death will be registered until end of study period (total three years) | — |
Countries
Denmark
Contacts
Public ContactDepartment of HPB Surgery
Oslo University Hospital
Outcome results
None listed