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

Phase 3Active Not RecruitingNCT02301286

Leiden University770 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

770

Conditions

Colon Cancer Adjuvant Therapy

Interventions

Acetylsalicylic acidDRUG

Placebo Acetylsalicylic acidDRUG

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (32)

Ziekenhuisgroep Twente

Almelo, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

Disease Free Survival

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 frame: 5 years

Time to Treatment Failure

The time elapsed between randomisation until treatment discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest.

Time frame: 5 years

Data from ClinicalTrials.gov

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