Aspirin for Prevention of Postsurgical Recurrence and Metastasis in Asian Colorectal Cancer Patients: a Multi-center Randomized Trial (APREMEC)
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|ClinicalTrials.gov Identifier: NCT02607072|
Recruitment Status : Recruiting
First Posted : November 17, 2015
Last Update Posted : November 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Acetylsalicylic acid (ASA)/aspirin 200 mg daily Drug: Acetylsalicylic acid (ASA)/aspirin 100 mg daily Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Enteric-coated Aspirin for Prevention of Postsurgical Recurrence and Metastasis in Asian Colorectal Cancer Patients (the APREMEC Trial): a Large-scale Multicenter Randomized Double-blind Placebo-controlled Trial|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2022|
Experimental: Aspirin 200 mg daily
Aspirin 200 mg daily
|Drug: Acetylsalicylic acid (ASA)/aspirin 200 mg daily|
Experimental: Aspirin 100 mg daily
Aspirin 100 mg daily
|Drug: Acetylsalicylic acid (ASA)/aspirin 100 mg daily|
Placebo Comparator: Placebo control
- 3-year disease free survival [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607072
|Contact: Lei Huang, PhD, MD, MSc, MBBSfirstname.lastname@example.org|
|The Fourth Affiliated Hospital of Anhui Medical University||Recruiting|
|Hefei, Anhui, China, 230000|
|Contact: A-Man Xu, MD, MBBS +86-551-65334247 email@example.com|