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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
Sponsor:
Collaborators:
Kom Op Tegen Kanker
Anticancerfund
Information provided by (Responsible Party):
ethisch.comite@uza.be, University Hospital, Antwerp

Study Description
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Brief Summary:
The purpose of this study is to determine whether acetylsalicylic acid is effective on the recurrence and survival of colon cancer patients.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: acetylsalicylic acid Drug: Placebo Phase 3

Detailed Description:
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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arms and Interventions
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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.
 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.
 Drug: Placebo
Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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
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Contact: Silke Raats, Bach +3238214215 aspirin@uza.be
Contact: Sven De Keersmaecker, Bach +3238214279 aspirin@uza.be

Locations
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Sponsors and Collaborators
University Hospital, Antwerp
Kom Op Tegen Kanker
Anticancerfund
Investigators
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Principal Investigator: Marc Peeters, MD PhD University Hospital, Antwerp
  Study Documents (Full-Text)

Documents provided by ethisch.comite@uza.be, University Hospital, Antwerp:
Study Protocol and Statistical Analysis Plan  [PDF] March 26, 2020

More Information
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Additional Information:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ethisch.comite@uza.be, University Hospital, Antwerp:
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