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

NCT ID: NCT02607072

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2022-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Aspirin 200 mg daily

Aspirin 200 mg daily

Group Type EXPERIMENTAL

Acetylsalicylic acid (ASA)/aspirin 200 mg daily

Intervention Type DRUG

Aspirin 100 mg daily

Aspirin 100 mg daily

Group Type EXPERIMENTAL

Acetylsalicylic acid (ASA)/aspirin 100 mg daily

Intervention Type DRUG

Placebo control

Placebo control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Acetylsalicylic acid (ASA)/aspirin 200 mg daily

Intervention Type DRUG

Acetylsalicylic acid (ASA)/aspirin 100 mg daily

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* This is a double-blind, placebo-controlled, randomized trial investigating aspirin application in tumor-nodal-metastasis (TNM) stages I-III CRC without metastasis requiring surgical resection. Patients ≥ 18 years who have their primary tumors (and metastatic lymph nodes) completely removed with R0 resection margin, and who have completed standard adjuvant therapy within 3 months without bleeding potential (e.g., platelet count ≥ 100 000/mm3) or other contradictions to aspirin will be eligible for this trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

The Fourth Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role lead

Responsible Party

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Lei Huang

Chief doctor, PhD, MD, MSc, MBBS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Fourth Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Huang, PhD, MD, MSc, MBBS

Role: CONTACT

[email protected]
+49-17680655141

Facility Contacts

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A-Man Xu, MD, MBBS

Role: primary

[email protected]
+86-551-65334247

Other Identifiers

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APREMEC-01

Identifier Type: -

Identifier Source: org_study_id