Trial record 1 of 1 for:
NCT03464305
ASPIRIN Trial Belgium (ASPIRIN)
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| ClinicalTrials.gov Identifier: NCT03464305 |
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Recruitment Status :
Recruiting
First Posted : March 14, 2018
Last Update Posted : March 10, 2020
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Sponsor:
University Hospital, Antwerp
Collaborators:
Kom Op Tegen Kanker
Anticancerfund
Information provided by (Responsible Party):
Ethisch Comité, UZA, University Hospital, Antwerp
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Brief Summary:
The purpose of this study is to determine whether acetylsalicylic acidis effective on the recurrence and survival of colon cancer patients.
Condition or disease: Colon Cancer (Adjuvant Therapy) Intervention: Drug: Acetylsalicylic acid; Drug: Placebo Acetylsalicylic acid Phase 3
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colon Cancer | Drug: acetylsalicylic acid Drug: Placebo | Phase 3 |
The purpose of this study is to determine the effect of 80mg acetylsalicylic acid (given orally once daily for 5 years) on 5 year overall survival (OS) for stage II and III colon cancer patients of 45 years of age and older. Preclinical, epidemiologic and clinical evidence suggest that acetylsalicylic acid use may reduce overall cancer risk and mortality in colon cancer patients. It is a phase III double blind placebo controlled, randomized trial of adjuvant low-dose acetylsalicylic acid in colon cancer patients. Patients will be stratified at randomization by centre, age (<70 and ≥70 years) chemotherapy use (any versus none) and disease stage.
| 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 |
|---|---|
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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 |
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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. |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Disease Free Survival [ Time Frame: 5 years ]he 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 |
Criteria
Inclusion Criteria:
- Age ≥45 years
- Patients must have TNM stage that is one of the following: pT3-4; N0-2 and M0, or pT1-2 and N1-2 (UICC stage II and III) (in case of >1 tumour: largest tumour is stage II or III)
- Patients must have completed surgical resection (R0) (both laparoscopic and open surgery) within 12 weeks of randomisation
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
- Patients currently taking acetylsalicylic acid 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)
- 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 a history of other malignancies in the last 5 years, except for SCC or CIN.
- 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
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): NCT03464305
Contacts
| Contact: Marjon De Roose, MSc | +3238214082 | aspirin@uza.be | |
| Contact: Silke Raats, Bach | +3238214215 | aspirin@uza.be |
Locations
Show 29 study locations
Sponsors and Collaborators
University Hospital, Antwerp
Kom Op Tegen Kanker
Anticancerfund
Investigators
| Principal Investigator: | Marc Peeters, MD PhD | University Hospital, Antwerp |
| Responsible Party: | Ethisch Comité, UZA, 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: | March 10, 2020 |
| Last Verified: | March 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Ethisch Comité, UZA, University Hospital, Antwerp:
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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 |
Additional relevant MeSH terms:
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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 |