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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2024 |
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Main ID: |
NCT03464305 |
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Date of registration:
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07/03/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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ASPIRIN Trial Belgium
ASPIRIN |
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Scientific title:
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A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients |
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Date of first enrolment:
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February 22, 2018 |
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Target sample size:
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148 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03464305 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Marc Peeters, Prof dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Antwerp |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients 45 years and older with histologically confirmed adenocarcinoma of the colon
- Patients must have TNM stage that is one of the following: pT3-4; N0-2 and M0, or
pT1-2 and N1-2 (Union for International Cancer Control (UICC) stage II and III) (in
case of >1 tumour: more advanced tumour is stage II or III)
- Patients must have completed surgical resection (R0) (both laparoscopic and open
surgery) within 12 weeks of randomization
Exclusion Criteria:
- Patients with rectal cancer (defined as tumour within 15 cm from the anal verge)
- Patients currently taking oral anti-coagulants or use of LMWH or use of DOACs
- Patients currently taking (low-dose) acetylsalicylic acid or other anti-aggregantia
for any reason
- Patients with a history of bleeding disorders or active gastric or duodenal ulcers
- Patients currently taking high dose systemic glucocorticoids (= 30 mg predniso(lo)n or
equivalent)
- Patients with (suspected) (non-) polyposis syndrome (FAP/AFAP, MAP, Lynch syndrome)
- Patients with >100 polyps of the colon or a known hereditary syndrome of the colon in
a first degree family member
- Allergy or intolerance to salicylates
- Patients with local or distant recurrent disease
- Previous malignancies other than CIN or SCC with a disease free survival less than 5
years
- Presence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule; those
conditions should be discussed with the patient before registration in the trial
Age minimum:
45 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colon Cancer
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Intervention(s)
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Drug: acetylsalicylic acid
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Drug: Placebo
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Primary Outcome(s)
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5 year overall survival
[Time Frame: 5 years]
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Secondary Outcome(s)
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Time to Treatment Failure
[Time Frame: 5 years]
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Disease Free Survival
[Time Frame: 5 years]
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Secondary ID(s)
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BE 2017-001397-41
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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