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

Phase 3

Active, not recruiting

• Conditions: Adjuvant Therapy; Colon Cancer
• Interventions: Drug: Acetylsalicylic acid; Drug: Placebo Acetylsalicylic acid

• Registration Number: NCT02301286
• Lead Sponsor: Leiden University

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.

Study Timeline

• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-25
• Study Start: 2015-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 770

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin	Acetylsalicylic acid	Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.
Placebo	Placebo Acetylsalicylic acid	Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.

Primary Outcome Measures

Name	Time	Method
5 year overall survival	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.

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival	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	5 years	The time elapsed between randomisation until treatment discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest.

Trial Locations

Locations (32)

Ziekenhuis St. Jansdal; 🇳🇱 Harderwijk, Netherlands

Antonius Ziekenhuis; 🇳🇱 Sneek, Netherlands

Deventer Ziekenhuis; 🇳🇱 Deventer, Netherlands

Slingeland Ziekenhuis; 🇳🇱 Doetinchem, Netherlands

Maxima MC; 🇳🇱 Eindhoven, Netherlands

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands

NijSmellinghe; 🇳🇱 Drachten, Netherlands

Meander MC; 🇳🇱 Amersfoort, Netherlands

Wilhelmina Ziekenhuis; 🇳🇱 Assen, Netherlands

Ziekenhuisgroep Twente; 🇳🇱 Almelo, Netherlands

ETZ; 🇳🇱 Tilburg, Netherlands

Reinier de Graaf Gasthuis; 🇳🇱 Delft, Netherlands

IJsselland Ziekenhuis; 🇳🇱 Capelle aan den IJssel, Netherlands

Ziekenhuis Gelderse Vallei; 🇳🇱 Ede, Netherlands

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

MST; 🇳🇱 Enschede, Netherlands

Admiraal de Ruijter Ziekenhuis; 🇳🇱 Goes, Netherlands

Groene Hart Ziekenhuis; 🇳🇱 Gouda, Netherlands

Beatrix Ziekenhuis; 🇳🇱 Gorinchem, Netherlands

Spaarne Gasthuis; 🇳🇱 Hoofddorp, Netherlands

Elkerliek Ziekenhuis; 🇳🇱 Helmond, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Alrijne Ziekenhuis; 🇳🇱 Leiderdorp, Netherlands

Ikazia Ziekenhuis; 🇳🇱 Rotterdam, Netherlands

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

ZorgSaam Zeeuws Vlaanderen; 🇳🇱 Terneuzen, Netherlands

Diakonessenhuis; 🇳🇱 Utrecht, Netherlands

HAGA ziekenhuis; 🇳🇱 The Hague, Netherlands

VieCuri Medisch Centrum; 🇳🇱 Venlo, Netherlands

Streekziekenhuis Koningin Beatrix (SKB); 🇳🇱 Winterswijk, Netherlands

Lange Land Ziekenhuis; 🇳🇱 Zoetermeer, Netherlands

HMC; 🇳🇱 Leidschendam, Netherlands