A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
A Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
Sponsors
Source
Leiden University Medical Center
Oversight Info
Has Dmc
Yes
Brief Summary
The purpose of this study is to determine whether acetylsalicylic acidis effective on the
recurrence and survival of colon cancer patients.
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.
Overall Status
Recruiting
Start Date
2014-09-01
Completion Date
2022-09-01
Primary Completion Date
2022-09-01
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
5 year overall survival |
5 years |
Secondary Outcome
Measure |
Time Frame |
|
Disease Free Survival |
5 years |
|
Time to Treatment Failure |
5 years |
Enrollment
1588
Conditions
Intervention
Intervention Type
Drug
Intervention Name
Arm Group Label
Placebo
Other Name
Placebo
Eligibility
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
Gender
All
Minimum Age
45 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
G.J. Liefers, MD PhD |
Principal Investigator |
Leiden University Medical Center |
|
J.E.A. Portielje, Professor |
Principal Investigator |
Leiden University Medical Center |
|
R. Fodde, Professor |
Principal Investigator |
Erasmus Medisch Centrum |
Overall Contact
Location
Facility |
Status |
Contact |
|
Ziekenhuisgroep Twente Almelo Netherlands |
Recruiting |
Last Name: E.A. Kouwenhoven, MD PhD |
|
Meander MC Amersfoort Netherlands |
Recruiting |
Last Name: E.C.J. Consten, MD Phd |
|
OLVG Amsterdam Netherlands |
Recruiting |
Last Name: S. Festen, MD PhD |
|
Wilhelmina Ziekenhuis Assen Netherlands |
Recruiting |
Last Name: P. Nieboer, MD PhD |
|
Amphia Ziekenhuis Breda Netherlands |
Recruiting |
Last Name: O.J.L. Loosveld, MD |
|
IJsselland Ziekenhuis Capelle aan den IJssel Netherlands |
Recruiting |
Last Name: D.F.S. Kehrer, MD Phd |
|
Reinier de Graaf Gasthuis Delft Netherlands |
Recruiting |
Last Name: J.W.T. Dekker, MD Phd |
|
Deventer Ziekenhuis Deventer Netherlands |
Recruiting |
Last Name: L.W. Kessels, MD |
|
Slingeland Ziekenhuis Doetinchem Netherlands |
Recruiting |
Last Name: C. Van Arkel, MD PhD |
|
NijSmellinghe Drachten Netherlands |
Recruiting |
Last Name: H. Van Der Mijle, MD PhD |
|
Ziekenhuis Gelderse Vallei Ede Netherlands |
Recruiting |
Last Name: A. Baars, MD PhD |
|
Catharina Ziekenhuis Eindhoven Netherlands |
Recruiting |
Last Name: G.J. Creemers, MD PhD |
|
Maxima MC Eindhoven Netherlands |
Recruiting |
Last Name: G.D. Slooter, MD Phd |
|
MST Enschede Netherlands |
Recruiting |
Last Name: E.B. Van Duyn, MD |
|
Admiraal de Ruijter Ziekenhuis Goes Netherlands |
Recruiting |
Last Name: H.K. Halteren, MD |
|
Beatrix Ziekenhuis Gorinchem Netherlands |
Recruiting |
Last Name: M. Davidis, MD |
|
Groene Hart Ziekenhuis Gouda Netherlands |
Recruiting |
Last Name: C.I.M. Baeten, MD PhD |
|
Kennemer Gasthuis Haarlem Netherlands |
Recruiting |
Last Name: H.B.A.C. Stockmann, MD PhD |
|
Ziekenhuis St. Jansdal Harderwijk Netherlands |
Recruiting |
Last Name: M. Temizkan, MD |
|
Elkerliek Ziekenhuis Helmond Netherlands |
Recruiting |
Last Name: J. Vincent, MD |
|
Spaarne Ziekenhuis Hoofddorp Netherlands |
Recruiting |
Last Name: B. De Valk, MD PhD |
|
Leiden University Medical Center Leiden Netherlands |
Recruiting |
Last Name: G.J. Liefers, MD PhD |
|
Alrijne Ziekenhuis Leiderdorp Netherlands |
Recruiting |
Last Name: P.A. Neijenhuis, MD |
|
HMC Leidschendam Netherlands |
Recruiting |
Last Name: A.W.K.S. Marinelli, MD PhD |
|
MC Zuiderzee Lelystad Netherlands |
Recruiting |
Last Name: R.M. Smeenk, MD PhD |
|
St. Antonius Ziekenhuis Nieuwegein Netherlands |
Recruiting |
Last Name: M. Los, MD PhD |
|
Ikazia Ziekenhuis Rotterdam Netherlands |
Recruiting |
Last Name: B. Toorenvliet, MD PhD |
|
Antonius Ziekenhuis Sneek Netherlands |
Recruiting |
Last Name: G.J. Veldhuis, MD PhD |
|
ZorgSaam Zeeuws Vlaanderen Terneuzen Netherlands |
Recruiting |
Last Name: M. Van Dijk, MD PhD |
|
HAGA ziekenhuis The Hague Netherlands |
Recruiting |
Last Name: J.E.A. Portielje, MD PhD |
|
ETZ Tilburg Netherlands |
Recruiting |
Last Name: R.J. Van Alphen, MD |
|
VieCuri Medisch Centrum Venlo Netherlands |
Recruiting |
Last Name: A.J. Van De Wouw, MD PhD |
|
Streekziekenhuis Koningin Beatrix (SKB) Winterswijk Netherlands |
Recruiting |
Last Name: P.P.J.B.M. Schiphorst, MD PhD |
|
Lange Land Ziekenhuis Zoetermeer Netherlands |
Recruiting |
Last Name: A.J.M. Van der Pas, MD PhD |
Location Countries
Country
Netherlands
Verification Date
2018-04-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Leiden University Medical Center
Investigator Full Name
GJLiefers
Investigator Title
Surgical Oncologist
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Aspirin
Arm Group
Arm Group Label
Aspirin
Arm Group Type
Experimental
Description
Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.
Arm Group Label
Placebo
Arm Group Type
Placebo Comparator
Description
Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
Firstreceived Results Date
N/A
Acronym
ASPIRIN
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
November 7, 2014
Study First Submitted Qc
November 21, 2014
Study First Posted
November 25, 2014
Last Update Submitted
April 11, 2018
Last Update Submitted Qc
April 11, 2018
Last Update Posted
April 12, 2018
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.