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

NCT ID: NCT02301286

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 770 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2027-12-31

Brief Summary

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

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.

Conditions

Colon Cancer; Adjuvant Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Aspirin

Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.

Group Type: EXPERIMENTAL

Acetylsalicylic acid

Intervention Type: DRUG

Placebo

Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.

Group Type: PLACEBO_COMPARATOR

Placebo Acetylsalicylic acid

Intervention Type: DRUG

Interventions

Acetylsalicylic acid

Intervention Type: DRUG

Placebo Acetylsalicylic acid

Intervention Type: DRUG

Other Intervention Names

Aspirin; Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stichting voor Patienten met Kanker aan het Spijsverteringskanaal (SPKS)

UNKNOWN

Sponsor Role: collaborator

Dutch Colorectal Cancer Group

OTHER

Sponsor Role: collaborator

Stichting Geriatrische Oncologie Nederland (GeriOnNe)

UNKNOWN

Sponsor Role: collaborator

Fonds NutsOhra

OTHER

Sponsor Role: collaborator

Innovatiefonds Zorgverzekeraars

OTHER

Sponsor Role: collaborator

Leiden University

OTHER

Sponsor Role: lead

Responsible Party

GJLiefers

Surgical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

G.J. Liefers, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

J.E.A. Portielje, Professor

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

R. Fodde, Professor

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medisch Centrum

Locations

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

Countries

Netherlands

Other Identifiers

P14.152

Identifier Type: -

Identifier Source: org_study_id