A Phase 3 interventional study of Acetylsalicylic acid and Placebo Acetylsalicylic acid in Colon Cancer and Adjuvant Therapy, sponsored by Leiden University. Active, not recruiting at 32 sites in Netherlands. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Leiden University · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether acetylsalicylic acidis effective on the recurrence and survival of colon cancer patients.
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 770 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Leiden University is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
Drug: Placebo Acetylsalicylic acid
Also known as: Aspirin
Also known as: Placebo
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.
Time frame: 5 years
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.
Time frame: 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.
Time frame: 5 years
This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Leiden University