ASPIRIN Trial Belgium (ASPIRIN)
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ClinicalTrials.gov Identifier: NCT03464305 |
Recruitment Status :
Recruiting
First Posted : March 14, 2018
Last Update Posted : December 22, 2020
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Condition or disease | Intervention/treatment | Phase |
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Colon Cancer | Drug: acetylsalicylic acid Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients |
Actual Study Start Date : | February 22, 2018 |
Estimated Primary Completion Date : | December 31, 2026 |
Estimated Study Completion Date : | December 31, 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Aspirin
Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.
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Drug: acetylsalicylic acid
Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy. |
Placebo Comparator: Placebo
Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
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Drug: Placebo
Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy. |
- 5 year overall survival [ Time Frame: 5 years ]The time to an event for OS is defined as the time interval between the date of randomisation and the date of death.
- Disease Free Survival [ Time Frame: 5 years ]The time to an event for DFS is defined as the time interval between the date of randomisation and the date of disease recurrence or death, whichever comes first. Recurrence of a disease can be a loco-regional recurrence, a distant recurrence or a new primary colon cancer. The evidence for recurrence must be documented in the patients' file.
- Time to Treatment Failure [ Time Frame: 5 years ]The time elapsed between randomisation until treatment discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest.

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Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT03464305
Contact: Silke Raats, Bach | +3238214215 | aspirin@uza.be | |
Contact: Sven De Keersmaecker, Bach | +3238214279 | aspirin@uza.be |

Principal Investigator: | Marc Peeters, MD PhD | University Hospital, Antwerp |
Documents provided by ethisch.comite@uza.be, University Hospital, Antwerp:
Responsible Party: | ethisch.comite@uza.be, Prof. dr. Marc Peeters, Diensthoofd Oncologie, University Hospital, Antwerp |
ClinicalTrials.gov Identifier: | NCT03464305 |
Other Study ID Numbers: |
BE 2017-001397-41 |
First Posted: | March 14, 2018 Key Record Dates |
Last Update Posted: | December 22, 2020 |
Last Verified: | December 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Colonic Diseases Aspirin Recurrence Digestive System Diseases Intestinal Diseases Disease Attributes Pathologic Processes |
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Aspirin 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 Enzyme Inhibitors Antipyretics |