Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients (ASPIRIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02301286
Recruitment Status : Recruiting
First Posted : November 25, 2014
Last Update Posted : April 12, 2018
Sponsor:
Collaborators:
Stichting voor Patienten met Kanker aan het Spijsverteringskanaal (SPKS)
Dutch Colorectal Cancer Group
Stichting Geriatrische Oncologie Nederland (GeriOnNe)
Fonds NutsOhra
Innovatiefonds Zorgverzekeraars
Information provided by (Responsible Party):
GJLiefers, Leiden University Medical Center

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 Intervention/treatment Phase
Colon Cancer Adjuvant Therapy Drug: Acetylsalicylic acid Drug: Placebo Acetylsalicylic acid 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1588 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
Study Start Date : September 2014
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

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
Other Name: Aspirin

Placebo Comparator: Placebo
Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
Drug: Placebo Acetylsalicylic acid
Other Name: Placebo




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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): NCT02301286


Contacts
Layout table for location contacts
Contact: J.P.B.M. Braak 0031715263500 datacenter@lumc.nl

Locations
Layout table for location information
Netherlands
Ziekenhuisgroep Twente Recruiting
Almelo, Netherlands
Contact: E.A. Kouwenhoven, MD PhD         
Meander MC Recruiting
Amersfoort, Netherlands
Contact: E.C.J. Consten, MD Phd         
OLVG Recruiting
Amsterdam, Netherlands
Contact: S. Festen, MD PhD         
Wilhelmina Ziekenhuis Recruiting
Assen, Netherlands
Contact: P. Nieboer, MD PhD         
Amphia Ziekenhuis Recruiting
Breda, Netherlands
Contact: O.J.L. Loosveld, MD         
IJsselland Ziekenhuis Recruiting
Capelle aan den IJssel, Netherlands
Contact: D.F.S. Kehrer, MD Phd         
Reinier de Graaf Gasthuis Recruiting
Delft, Netherlands
Contact: J.W.T. Dekker, MD Phd         
Deventer Ziekenhuis Recruiting
Deventer, Netherlands
Contact: L.W. Kessels, MD         
Slingeland Ziekenhuis Recruiting
Doetinchem, Netherlands
Contact: C. Van Arkel, MD PhD         
NijSmellinghe Recruiting
Drachten, Netherlands
Contact: H. Van Der Mijle, MD PhD         
Ziekenhuis Gelderse Vallei Recruiting
Ede, Netherlands
Contact: A. Baars, MD PhD         
Catharina Ziekenhuis Recruiting
Eindhoven, Netherlands
Contact: G.J. Creemers, MD PhD         
Maxima MC Recruiting
Eindhoven, Netherlands
Contact: G.D. Slooter, MD Phd         
MST Recruiting
Enschede, Netherlands
Contact: E.B. Van Duyn, MD         
Admiraal de Ruijter Ziekenhuis Recruiting
Goes, Netherlands
Contact: H.K. Halteren, MD         
Beatrix Ziekenhuis Recruiting
Gorinchem, Netherlands
Contact: M. Davidis, MD         
Groene Hart Ziekenhuis Recruiting
Gouda, Netherlands
Contact: C.I.M. Baeten, MD PhD         
Kennemer Gasthuis Recruiting
Haarlem, Netherlands
Contact: H.B.A.C. Stockmann, MD PhD         
Ziekenhuis St. Jansdal Recruiting
Harderwijk, Netherlands
Contact: M. Temizkan, MD         
Elkerliek Ziekenhuis Recruiting
Helmond, Netherlands
Contact: J. Vincent, MD         
Spaarne Ziekenhuis Recruiting
Hoofddorp, Netherlands
Contact: B. De Valk, MD PhD         
Leiden University Medical Center Recruiting
Leiden, Netherlands
Contact: G.J. Liefers, MD PhD         
Alrijne Ziekenhuis Recruiting
Leiderdorp, Netherlands
Contact: P.A. Neijenhuis, MD         
HMC Recruiting
Leidschendam, Netherlands
Contact: A.W.K.S. Marinelli, MD PhD         
MC Zuiderzee Recruiting
Lelystad, Netherlands
Contact: R.M. Smeenk, MD PhD         
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands
Contact: M. Los, MD PhD         
Ikazia Ziekenhuis Recruiting
Rotterdam, Netherlands
Contact: B. Toorenvliet, MD PhD         
Antonius Ziekenhuis Recruiting
Sneek, Netherlands
Contact: G.J. Veldhuis, MD PhD         
ZorgSaam Zeeuws Vlaanderen Recruiting
Terneuzen, Netherlands
Contact: M. Van Dijk, MD PhD         
Contact: M.P.S. Sie, MD PhD         
HAGA ziekenhuis Recruiting
The Hague, Netherlands
Contact: J.E.A. Portielje, MD PhD         
ETZ Recruiting
Tilburg, Netherlands
Contact: R.J. Van Alphen, MD         
VieCuri Medisch Centrum Recruiting
Venlo, Netherlands
Contact: A.J. Van De Wouw, MD PhD         
Streekziekenhuis Koningin Beatrix (SKB) Recruiting
Winterswijk, Netherlands
Contact: P.P.J.B.M. Schiphorst, MD PhD         
Lange Land Ziekenhuis Recruiting
Zoetermeer, Netherlands
Contact: A.J.M. Van der Pas, MD PhD         
Sponsors and Collaborators
Leiden University Medical Center
Stichting voor Patienten met Kanker aan het Spijsverteringskanaal (SPKS)
Dutch Colorectal Cancer Group
Stichting Geriatrische Oncologie Nederland (GeriOnNe)
Fonds NutsOhra
Innovatiefonds Zorgverzekeraars
Investigators
Layout table for investigator information
Principal Investigator: G.J. Liefers, MD PhD Leiden University Medical Center
Principal Investigator: J.E.A. Portielje, Professor Leiden University Medical Center
Principal Investigator: R. Fodde, Professor Erasmus Medisch Centrum

Layout table for additonal information
Responsible Party: GJLiefers, Surgical Oncologist, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT02301286     History of Changes
Other Study ID Numbers: P14.152
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Keywords provided by GJLiefers, Leiden University Medical Center:
Acetylsalicylic acid
Colon cancer
Survival

Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Recurrence
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
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