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

March 15, 2024 updated by: GJLiefers, Leiden University

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

770

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Almelo, Netherlands
        • Ziekenhuisgroep Twente
      • Amersfoort, Netherlands
        • Meander MC
      • Assen, Netherlands
        • Wilhelmina Ziekenhuis
      • Breda, Netherlands
        • Amphia Ziekenhuis
      • Capelle aan den IJssel, Netherlands
        • IJsselland ziekenhuis
      • Delft, Netherlands
        • Reinier de Graaf Gasthuis
      • Deventer, Netherlands
        • Deventer Ziekenhuis
      • Doetinchem, Netherlands
        • Slingeland Ziekenhuis
      • Drachten, Netherlands
        • Nijsmellinghe
      • Ede, Netherlands
        • Ziekenhuis Gelderse Vallei
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Eindhoven, Netherlands
        • Maxima MC
      • Enschede, Netherlands
        • MST
      • Goes, Netherlands
        • Admiraal de Ruijter Ziekenhuis
      • Gorinchem, Netherlands
        • Beatrix Ziekenhuis
      • Gouda, Netherlands
        • Groene Hart Ziekenhuis
      • Harderwijk, Netherlands
        • Ziekenhuis St. Jansdal
      • Helmond, Netherlands
        • Elkerliek Ziekenhuis
      • Hoofddorp, Netherlands
        • Spaarne Gasthuis
      • Leiden, Netherlands
        • Leiden University Medical Center
      • Leiderdorp, Netherlands
        • Alrijne Ziekenhuis
      • Leidschendam, Netherlands
        • HMC
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis
      • Rotterdam, Netherlands
        • Ikazia Ziekenhuis
      • Sneek, Netherlands
        • Antonius Ziekenhuis
      • Terneuzen, Netherlands
        • ZorgSaam Zeeuws Vlaanderen
      • The Hague, Netherlands
        • Haga ziekenhuis
      • Tilburg, Netherlands
        • ETZ
      • Utrecht, Netherlands
        • Diakonessenhuis
      • Venlo, Netherlands
        • VieCuri Medisch Centrum
      • Winterswijk, Netherlands
        • Streekziekenhuis Koningin Beatrix (SKB)
      • Zoetermeer, Netherlands
        • Lange Land Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aspirin
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 Names:
  • Aspirin
Placebo Comparator: Placebo
Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
Drug: Placebo Acetylsalicylic acid
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University

Collaborators

Fonds NutsOhra
Dutch Colorectal Cancer Group
Innovatiefonds Zorgverzekeraars
Stichting voor Patienten met Kanker aan het Spijsverteringskanaal (SPKS)
Stichting Geriatrische Oncologie Nederland (GeriOnNe)

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimated)

November 25, 2014

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P14.152

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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