A Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether acetylsalicylic acidis effective on the recurrence and survival of colon cancer patients.

Detailed Description
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The purpose of this study is to determine the 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. Preclinical, epidemiologic and clinical evidence suggest that acetylsalicylic acid use may reduce overall cancer risk and mortality in colon cancer patients. It is a phase III double blind placebo controlled, randomized trial of adjuvant low-dose acetylsalicylic acid in colon cancer patients. Patients will be stratified at randomization by centre, age (<70 and ≥70 years) chemotherapy use (any versus none) and disease stage.

Official Title
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A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients

Conditions
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Colon Cancer, Adjuvant Therapy

Intervention / Treatment
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* Drug: Acetylsalicylic acid
* Drug: Placebo Acetylsalicylic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥45 years 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 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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin<br>Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy. | Drug: Acetylsalicylic acid<br> <br> * Other names: Aspirin;|
| Placebo Comparator: Placebo<br>Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy. | Drug: Placebo Acetylsalicylic acid<br> <br> * Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 year overall survival | The time to an event for OS is defined as the time interval between the date of randomisation and the date of death. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival | 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. Recurrence of a disease can be a loco-regional recurrence, a distant recurrence or a new primary colon cancer. The evidence for recurrence must be documented in the patients' file. | 5 years | 
| Time to Treatment Failure | The time elapsed between randomisation until treatment discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetylsalicylic acid, Colon cancer, Survival