A Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients (ASPIRIN)
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|ClinicalTrials.gov Identifier: NCT02301286|
Recruitment Status : Recruiting
First Posted : November 25, 2014
Last Update Posted : February 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Adjuvant Therapy||Drug: Acetylsalicylic acid Drug: Placebo Acetylsalicylic acid||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1588 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients|
|Actual Study Start Date :||January 2015|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2022|
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
Other Name: Aspirin
Placebo Comparator: Placebo
Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
Drug: Placebo Acetylsalicylic acid
Other Name: Placebo
- 5 year overall survival [ Time Frame: 5 years ]The time to an event for OS is defined as the time interval between the date of randomisation and the date of death.
- Disease Free Survival [ Time Frame: 5 years ]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 to Treatment Failure [ Time Frame: 5 years ]The time elapsed between randomisation until treatment discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301286
|Contact: J.P.B.M. Braakfirstname.lastname@example.org|
|Principal Investigator:||G.J. Liefers, MD PhD||Leiden University Medical Center|
|Principal Investigator:||J.E.A. Portielje, Professor||Leiden University Medical Center|
|Principal Investigator:||R. Fodde, Professor||Erasmus Medisch Centrum|