Patients with resected colon carcinoma
Conditions
Interventions
Product Name: Aspirin
Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLSALICYLIC ACID
CAS Number: 50-78-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Sponsors
Antwerp University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients 45 years and older with histologically confirmed adenocarcinoma of the colon • Patients with histologically confirmed adenocarcinoma of the colon • Patients must have TNM stage that is one of the following: pT3-4; N0-2 and M0, or pT1-2 and N1-2 (UICC stage II and III) (in case of >1 tumour: more advanced tumour is stage II or III) • Patients who have undergone curative radical resection (R0 resection) within 12 weeks prior to study entry • Written informed consent according to national and local regulation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: • Patients with rectal cancer (defined as tumour within 15 cm from the anal verge). • Patients currently taking (low-dose) acetylsalicylic acid for any reason. • Patients currently taking oral anti-coagulants or use of LMWH • Patients with a history of bleeding disorders or active gastric or duodenal ulcers. • Patients currently taking high dose systemic glucocorticoids.(= 30 mg predniso(lo)n or equivalent) • Patients with (suspected) (non-) polyposis syndrome (FAP/AFAP, MAP, Lynch syndrome) • Patients with >100 polyps of the colon or a known hereditary syndrome of the colon in a first degree family member (father/mother/brother/sister/son/daughter) • Allergy or intolerance to salicylates • Patients with local or distant recurrent disease • Previous malignancies other than CIN or SCC with a disease free survival less than 5 years • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study effect of 80mg acetylsalicylic acid (given orally once daily for 5 years) on 5 year overall survival (OS) for stage II and III colon cancer patients;Secondary Objective: To study the effect of acetylsalicylic acid on 3 year disease free survival (DFS) • To study the effect of acetylsalicylic acid on time to treatment failure (TTF) • To study the effect of acetylsalicylic acid on toxicity, for example the interaction of acetylsalicylic acid with chemotherapy.;Primary end point(s): The primary endpoint is 5 year Overall Survival (5y-OS). The time to an event for OS is defined as the time interval between the date of randomisation and the date of death. A patient that is still alive at the last date of follow-up patient is censored for analysis and the time at risk corresponds to the time interval between the date of randomisation and the date of last follow up.;Timepoint(s) of evaluation of this end point: 5 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Disease Free Survival (DFS). The time to an event for DFS is defined as the time interval between the date of randomisation and the date of disease recurrence or death, whichever comes first. The date of radiological evidence, e.g. CT, MRI, etc, or colonoscopy will be considered as date of recurrence. • Time to Treatment Failure (TTF). The time elapsed between randomisation until treatment discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest.;Timepoint(s) of evaluation of this end point: Whenever disease recurs, disease progresses, toxicity issues arise or the patient dies. | — |
Countries
Belgium
Contacts
Public ContactProf. Dr. Marc Peeters
Antwerp University Hospital
Outcome results
None listed