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Trial record 19 of 470 for:    aspirin AND prevention

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:
Information provided by (Responsible Party):

Study Description
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.


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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Placebo control
Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. 3-year disease free survival [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Lei Huang, PhD, MD, MSc, MBBS +49-17680655141 lei.huang@dkfz-heidelberg.de

Locations
China, Anhui
The Fourth Affiliated Hospital of Anhui Medical University Recruiting
Hefei, Anhui, China, 230000
Contact: A-Man Xu, MD, MBBS    +86-551-65334247    amanxu@163.com   
Sponsors and Collaborators
The Fourth Affiliated Hospital of Anhui Medical University
The First Affiliated Hospital of Anhui Medical University
Anhui Provincial Hospital
More Information

Responsible Party: Lei Huang, Chief doctor, PhD, MD, MSc, MBBS, The Fourth Affiliated Hospital of Anhui Medical University
ClinicalTrials.gov Identifier: NCT02607072     History of Changes
Other Study ID Numbers: APREMEC-01
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by Lei Huang, The Fourth Affiliated Hospital of Anhui Medical University:
APREMEC, aspirin, colorectal cancer, adjuvant therapy, recurrence, metastasis, survival

Additional relevant MeSH terms:
Aspirin
Colorectal Neoplasms
Neoplasm Metastasis
Recurrence
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Disease Attributes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors