A Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
ASPIRIN
A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
1 other identifier
interventional
770
1 country
32
Brief Summary
The purpose of this study is to determine whether acetylsalicylic acidis effective on the recurrence and survival of colon cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2015
Longer than P75 for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2014
CompletedFirst Posted
Study publicly available on registry
November 25, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 18, 2024
March 1, 2024
12.9 years
November 7, 2014
March 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Disease Free Survival
5 years
Time to Treatment Failure
5 years
Study Arms (2)
Aspirin
EXPERIMENTALPatients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.
Placebo
PLACEBO COMPARATORPatients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leiden Universitylead
- Stichting voor Patienten met Kanker aan het Spijsverteringskanaal (SPKS)collaborator
- Dutch Colorectal Cancer Groupcollaborator
- Stichting Geriatrische Oncologie Nederland (GeriOnNe)collaborator
- Fonds NutsOhracollaborator
- Innovatiefonds Zorgverzekeraarscollaborator
Study Sites (32)
Ziekenhuisgroep Twente
Almelo, Netherlands
Meander MC
Amersfoort, Netherlands
Wilhelmina Ziekenhuis
Assen, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
IJsselland Ziekenhuis
Capelle aan den IJssel, Netherlands
Reinier de Graaf Gasthuis
Delft, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Slingeland Ziekenhuis
Doetinchem, Netherlands
NijSmellinghe
Drachten, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Maxima MC
Eindhoven, Netherlands
MST
Enschede, Netherlands
Admiraal de Ruijter Ziekenhuis
Goes, Netherlands
Beatrix Ziekenhuis
Gorinchem, Netherlands
Groene Hart Ziekenhuis
Gouda, Netherlands
Ziekenhuis St. Jansdal
Harderwijk, Netherlands
Elkerliek Ziekenhuis
Helmond, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Alrijne Ziekenhuis
Leiderdorp, Netherlands
HMC
Leidschendam, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Ikazia Ziekenhuis
Rotterdam, Netherlands
Antonius Ziekenhuis
Sneek, Netherlands
ZorgSaam Zeeuws Vlaanderen
Terneuzen, Netherlands
HAGA ziekenhuis
The Hague, Netherlands
ETZ
Tilburg, Netherlands
Diakonessenhuis
Utrecht, Netherlands
VieCuri Medisch Centrum
Venlo, Netherlands
Streekziekenhuis Koningin Beatrix (SKB)
Winterswijk, Netherlands
Lange Land Ziekenhuis
Zoetermeer, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Surgical Oncologist
Study Record Dates
First Submitted
November 7, 2014
First Posted
November 25, 2014
Study Start
January 1, 2015
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
March 18, 2024
Record last verified: 2024-03