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Trial record 17 of 3977 for:    colon cancer AND Colonic Diseases

ASPIRIN Trial Belgium (ASPIRIN)

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ClinicalTrials.gov Identifier: NCT03464305
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : January 10, 2019
Sponsor:
Collaborators:
Kom Op Tegen Kanker
Anticancerfund
Information provided by (Responsible Party):
Ethisch Comité, UZA, University Hospital, Antwerp

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

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.

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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

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.




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 ]
    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.

  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.



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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
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Contact: Marjon De Roose, MSc +3238214082 aspirin@uza.be
Contact: Lesley De Backer, MSc +3238215275 Lesley.DeBacker@uza.be

Locations
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Belgium
AZ Klina Recruiting
Brasschaat, Antwerpen, Belgium
Contact: Wim Demey, MD    +3236505053      
Contact: Sofie Herman    +3236505277      
Principal Investigator: Wim Demey, MD         
AZ Monica Not yet recruiting
Deurne, Antwerpen, Belgium, 2100
Contact: Kathleen Forceville, MD       Kathleen.Forceville@azmonica.be   
Principal Investigator: Kathleen Forceville, MD         
Heilige Familie Not yet recruiting
Rumst, Antwerpen, Belgium
Contact: Michel Craninx, MD       mcraninx@hfr.be   
Principal Investigator: Michel Craninx, MD         
Sint Jozefkliniek Recruiting
Bornem, Oost-Vlaanderen, Belgium, 2880
Contact: Tim Rondou, MD       Dr.Rondou@sjk.be   
Contact: Lisbeth Vandenabeele, MD       Dr.Vandenabeele@sjk.be   
Principal Investigator: Tim Rondou, MD         
Sub-Investigator: Lisbeth Vandenabeele, MD         
AZ Nikolaas Recruiting
Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
Contact: Koen Gorleer, MD         
Contact: Goele Wallays       Goele.Wallays@aznikolaas.be   
Principal Investigator: Koen Gorleer, MD         
Gasthuiszusters Ziekenhuizen Recruiting
Antwerpen, Belgium, 2610
Contact: Isabelle Maurissen, Dr       isabelle.maurissen@gza.be   
Principal Investigator: Isabelle Maurissen, Dr         
AZ Sint-Lucas Recruiting
Brugge, Belgium, 8310
Contact: Tania Maerten       tania.maerten@stlucas.be   
Principal Investigator: Annelies Holvoet, Dr         
AZ Sint-Blasius Recruiting
Dendermonde, Belgium, 9200
Contact: An Pieters, Dr       an.pieters@azsintblasius.be   
Principal Investigator: An Pieters, Dr         
Sub-Investigator: Marijke Paelinck, Dr         
AZ Alma Not yet recruiting
Eeklo, Belgium, 9900
Contact: Bart Sierens, Dr       bart.sierens@azalma.be   
Principal Investigator: Bart Sierens, Dr         
Sub-Investigator: Barbara Claerhout, Dr         
AZ Sint-Dimpna Not yet recruiting
Geel, Belgium, 2440
Contact: Arne Eyben, Dr       arne.eyben@ziekenhuisgeel.be   
Principal Investigator: Arne Eyben, Dr         
AZ Maria Middelares Not yet recruiting
Gent, Belgium, 9000
Contact: Katrien De Bosschere       katrien.debosschere@azmmsj.be   
Principal Investigator: Els Monsaert, Dr         
Sub-Investigator: Erik Vanderstraeten, Dr         
Jessa Ziekenhuis Not yet recruiting
Hasselt, Belgium, 3500
Contact: Marc Aerts       marc.aerts@jessazh.be   
Principal Investigator: Daan Walgraeve, Dr         
AZ Groeninge Recruiting
Kortrijk, Belgium, 8500
Contact: Fien Verplancke       fien.verplancke@azgroeninge.be   
Principal Investigator: Philippe Vergauwe, Dr         
RZ Heilig Hart Not yet recruiting
Leuven, Belgium, 3000
Contact: Ruben Spitaels, Dr       ruben.spitaels@hhleuven.be   
Principal Investigator: Ruben Spitaels, Dr         
Sub-Investigator: Alexander Goegebuer, Dr         
CHU UCL Namur Site de Sainte-Elisabeth Not yet recruiting
Namur, Belgium, 5000
Contact: Monique Gilsoul       monique.gilsoul@uclouvain.be   
Principal Investigator: Jean-Charles Goeminne, Dr         
AZ Glorieux Not yet recruiting
Ronse, Belgium, 9600
Contact: Charlotte Vantomme       charlotte.vantomme@azglorieux.be   
Principal Investigator: Bjorn Ghillemijn, Dr         
Sub-Investigator: Florence Van Ryckeghem, Dr         
AZ Sint-Trudo Not yet recruiting
Sint-Truiden, Belgium, 3800
Contact: Elien Dewaele, Dr       elien.dewaele@stzh.be   
Principal Investigator: Elien Dewaele, Dr         
AZ Vesalius Not yet recruiting
Tongeren, Belgium, 3717
Contact: Peter Van Lint, Dr       peter.vanlint@azvesalius.be   
Principal Investigator: Peter Van Lint, Dr         
OLV van Lourdes Ziekenhuis Not yet recruiting
Waregem, Belgium, 8790
Contact: Veronique Buyse, Dr       veronique.buyse@ziekenhuiswaregem.be   
Principal Investigator: Veronique Buyse, Dr         
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

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Responsible Party: Ethisch Comité, UZA, Prof. dr. Marc Peeters, Diensthoofd Oncologie, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03464305     History of Changes
Other Study ID Numbers: BE 2017-001397-41
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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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 Comité, UZA, University Hospital, Antwerp:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Aspirin
Recurrence
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