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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
Sponsor:
Collaborators:
The First Affiliated Hospital of Anhui Medical University
Anhui Provincial Hospital
Information provided by (Responsible Party):
Lei Huang, The Fourth Affiliated Hospital of Anhui Medical University

Tracking Information
First Submitted Date  ICMJE November 15, 2015
First Posted Date  ICMJE November 17, 2015
Last Update Posted Date November 18, 2015
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2015)
3-year disease free survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02607072 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin for Prevention of Postsurgical Recurrence and Metastasis in Asian Colorectal Cancer Patients: a Multi-center Randomized Trial
Official Title  ICMJE 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
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Acetylsalicylic acid (ASA)/aspirin 200 mg daily
  • Drug: Acetylsalicylic acid (ASA)/aspirin 100 mg daily
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Aspirin 200 mg daily
    Aspirin 200 mg daily
    Intervention: Drug: Acetylsalicylic acid (ASA)/aspirin 200 mg daily
  • Experimental: Aspirin 100 mg daily
    Aspirin 100 mg daily
    Intervention: Drug: Acetylsalicylic acid (ASA)/aspirin 100 mg daily
  • Placebo Comparator: Placebo control
    Placebo control
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2015)
3000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Exclusion Criteria:

  • Patients allergic to aspirin, receiving previous (within 3 months before surgery) or ongoing treatment with aspirin, other anti-platelet or anticoagulation agent, other Cox inhibitors, glucocorticoid, or drugs severely interfering with aspirin, with peptic ulcer, inflammatory bowel disease (e.g., ulcerative colitis and Crohn's disease), asthma, ischemic heart disease (IHD), class III/IV heart failure (as defined by the New York Heart Association), stroke, thrombotic event, peripheral vascular disease, uncontrolled hypertension, gout or severe liver or renal dysfunction, having undergone coronary artery bypass grafting within 3 months will be excluded from this trial. Other exclusion criteria are: colorectal non-malignant diseases (e.g., familial adenomatous polyposis, and adenoma); recurrent CRC; previous colorectal resection; malignancies other than CRC (excluding non-melanoma skin cancer) within 5 years before intake initiation; pregnancy or nursing; immunosuppressive therapy within 6 months; and enrollment in other CRC clinical trials.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lei Huang, PhD, MD, MSc, MBBS +49-17680655141 lei.huang@dkfz-heidelberg.de
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02607072
Other Study ID Numbers  ICMJE APREMEC-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lei Huang, The Fourth Affiliated Hospital of Anhui Medical University
Study Sponsor  ICMJE The Fourth Affiliated Hospital of Anhui Medical University
Collaborators  ICMJE
  • The First Affiliated Hospital of Anhui Medical University
  • Anhui Provincial Hospital
Investigators  ICMJE Not Provided
PRS Account The Fourth Affiliated Hospital of Anhui Medical University
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP