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

NCT02607072 | Unknown Phase 3 DMC

• 1 other identifier: APREMEC-01
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

APREMEC, aspirin, colorectal cancer, adjuvant therapy, recurrence, metastasis, survival

Outcome Measures

Primary Outcomes (1)

• 3-year disease free survival

  3 years

Study Arms (3)

Aspirin 200 mg daily

EXPERIMENTAL

Aspirin 200 mg daily

Drug: Acetylsalicylic acid (ASA)/aspirin 200 mg daily

Aspirin 100 mg daily

EXPERIMENTAL

Aspirin 100 mg daily

Drug: Acetylsalicylic acid (ASA)/aspirin 100 mg daily

Placebo control

PLACEBO COMPARATOR

Placebo control

Drug: Placebo

Interventions

Acetylsalicylic acid (ASA)/aspirin 200 mg daily DRUG

Aspirin 200 mg daily

Acetylsalicylic acid (ASA)/aspirin 100 mg daily DRUG

Aspirin 100 mg daily

Placebo DRUG

Placebo control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Anhui Medical University: lead
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Anhui Provincial Hospital: collaborator

Study Sites (1)

The Fourth Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Recurrence; Neoplasm Metastasis

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Lei Huang, PhD, MD, MSc, MBBS

CONTACT

+49-17680655141; lei.huang@dkfz-heidelberg.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief doctor, PhD, MD, MSc, MBBS

Study Record Dates

• First Submitted: November 15, 2015
• First Posted: November 17, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2022
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

CN (1)