Patients must have TNM stage that is one of the following: pT3-4
Conditions
Interventions
Trade Name: Aspirine
Product Name: Aspirin
Pharmaceutical Form: Tablet
INN or Proposed INN: Acetylsalicylic acid
CAS Number: 50-78-2
Other descriptive name: ACETYLSALICYLIC ACID
Concentration unit: m
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients 45 years and older 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: largest tumour is stage II or III) -Patients must have completed surgical resection (R0) (both laparoscopic and open surgery) within 12 weeks of randomisation -Written informed consent 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 750 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 838
Exclusion criteria
Exclusion criteria: -Patients with rectal cancer (defined as tumour within 15 cm from the anal verge) -Patients currently taking oral anti-coagulants or use of LMWH -Patients currently taking acetylsalicylic acid for any reason -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) -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 -Allergy or intolerance to salicylates. -Patients with a history of other malignancies in the last 5 years, except for SCC or CIN. -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 of 45 years of age and older. ;Secondary Objective: -To study the effect of acetylsalicylic acid on 3 year disease free survival (DFS) in patients 45 years of age or older with stage II and III colon cancer. -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 aspirin with chemotherapy. ;Primary end point(s): The primary endpoint of the trial is 5 year Overall Survival (5-yr OS). ;Timepoint(s) of evaluation of this end point: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -To study the effect of acetylsalicylic acid on 3 year disease free survival (DFS) in patients 45 years of age or older with stage II and III colon cancer. -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 aspirin with chemotherapy. ;Timepoint(s) of evaluation of this end point: 3 years | — |
Countries
Netherlands
Contacts
Public ContactStudy coordinator
Leiden University Medical Center
Outcome results
None listed