Colorectal CancerPhase 3APREMECNCT02607072
Aspirin for Prevention of Postsurgical Recurrence and Metastasis in Asian Colorectal Cancer Patients: a Multi-center Randomized Trial
A Phase 3 study testing Acetylsalicylic acid (ASA)/aspirin 200 mg daily and Acetylsalicylic acid (ASA)/aspirin 100 mg daily in people with Colorectal Cancer, run by The Fourth Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Acetylsalicylic acid (ASA)/aspirin 200 mg daily and Acetylsalicylic acid (ASA)/aspirin 100 mg daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Oct 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
A-Man Xu, MD, MBBS, +86-551-65334247, amanxu@163.com
About this study
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
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.
Read more
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
- Being tested
- Acetylsalicylic acid (ASA)/aspirin 200 mg daily, Acetylsalicylic acid (ASA)/aspirin 100 mg daily, Placebo
- Keywords
- APREMEC, aspirin, colorectal cancer, adjuvant therapy, recurrence, metastasis, survival
- Medical subject headings
- Colorectal Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acid (ASA)/aspirin 200 mg dailyDrug
Acetylsalicylic acid (ASA)/aspirin 100 mg dailyDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Aspirin 200 mg daily | Experimental | Aspirin 200 mg daily Receives: Drug: Acetylsalicylic acid (ASA)/aspirin 200 mg daily |
| Aspirin 100 mg daily | Experimental | Aspirin 100 mg daily Receives: Drug: Acetylsalicylic acid (ASA)/aspirin 100 mg daily |
| Placebo control | Placebo comparator | Placebo control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2020 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, Anhui Provincial Hospital
- Responsible party
- Principal investigator, Lei Huang, The Fourth Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607072
- Sponsor's protocol ID
- APREMEC-01
- Acronym
- APREMEC
- Status last verified
- Nov 2015
- First submitted
- 15 Nov 2015
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02607072
- Acronym / sponsor ID
- APREMEC / APREMEC-01
- Conditions
- Colorectal Cancer
- Keywords
- APREMEC, aspirin, colorectal cancer, adjuvant therapy, recurrence, metastasis, survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, Anhui Provincial Hospital
- Study start
- Oct 2015
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aspirin 200 mg daily | Experimental | Drug: Acetylsalicylic acid (ASA)/aspirin 200 mg dailyAspirin 200 mg daily |
| Aspirin 100 mg daily | Experimental | Drug: Acetylsalicylic acid (ASA)/aspirin 100 mg dailyAspirin 100 mg daily |
| Placebo control | Placebo comparator | Drug: PlaceboPlacebo control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
3-year disease free survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylsalicylic acid (ASA)/aspirin 200 mg daily and Acetylsalicylic acid (ASA)/aspirin 100 mg daily in people with Colorectal Cancer, run by The Fourth Affiliated Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Huang, PhD, MD, MSc, MBBS (+49-17680655141, lei.huang@dkfz-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.