Patients with resected colon carcinoma
Conditions
Brief summary
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.
Detailed description
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. 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. 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.
Interventions
DRUGPLACEBO
DRUGACETYLSALICYLIC ACID
Sponsors
Antwerp University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 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. 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. | — |
Countries
Belgium
Outcome results
None listed