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Aspirin for Prevention of Postsurgical Recurrence and Metastasis in Asian Colorectal Cancer Patients: a Multi-center Randomized Trial

NCT02607072 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2015-11-18

No results posted yet for this study

Summary

Background: Evidence of high quality has suggested that acetylsalicylic acid (ASA)/aspirin effectively reduces colorectal adenoma incidence and recurrence rate, and several randomized controlled trials (RCTs) strongly indicate its potential to prevent colorectal cancer (CRC) initiation and progression and to decrease cancer-related mortality. However the role of aspirin supplied as an adjuvant agent in postsurgical CRC patients remains obscure, and a RCT is warranted for clarification.

Aim: The APREMEC trial aims to investigate the potential preventative role of enteric-coated aspirin (100 mg and 200 mg daily) against postsurgical recurrence and metastasis among Asian CRC patients.

Design: The investigators hypothesize that this large-scale multicenter randomized double-blind placebo-controlled trial will support that aspirin can reduce recurrence and metastasis and improve survival in postsurgical non-metastasized CRC patients. The primary endpoint of this trial is disease-free survival, and the secondary endpoints are 3-year and 5-year overall survival, the interactive effects of lifestyle including smoking and alcohol ingestion, and adverse event rate. Eligible postoperative patients with non-metastasized CRC will be randomized in this trial to 100 mg aspirin, 200 mg aspirin or placebo until recurrence/metastasis, severe adverse event, death, or end of study, after standard adjuvant therapy. Individuals with peptic ulcer, bleeding tendency, or previous or ongoing treatment with aspirin or other anticoagulants will be excluded from this trial. Stratification factors are gender, study center, cancer site, and tumor stage. After randomization, patients will be followed up with evaluations at a 3-month interval while taking study drug.

Discussion: This study aims at investigation of aspirin's role as an adjuvant agent in prevention of postsurgical CRC recurrence and metastasis. If results turn out to be positive, Asian and global CRC patients will be greatly benefited, due to the fact that aspirin is inexpensive, easily-accessible, and simply-administered, with well know and managed adverse events.

Conditions

Interventions

DRUG

Acetylsalicylic acid (ASA)/aspirin 200 mg daily

DRUG

Acetylsalicylic acid (ASA)/aspirin 100 mg daily

DRUG

Placebo

Sponsors & Collaborators

  • The First Affiliated Hospital of Anhui Medical University

    collaborator OTHER

  • Anhui Provincial Hospital

    collaborator OTHER_GOV

  • The Fourth Affiliated Hospital of Anhui Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2020-10-31
Completion
2022-10-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02607072 on ClinicalTrials.gov