Clinical trial NCT02301286: A Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
Official title: A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Colon Cancer
Adjuvant Therapy
Keywords: Acetylsalicylic acid
Colon cancer
Survival
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Stichting voor Patienten met Kanker aan het Spijsverteringskanaal (SPKS)
name: Dutch Colorectal Cancer Group
name: Stichting Geriatrische Oncologie Nederland (GeriOnNe)
name: Fonds NutsOhra
name: Innovatiefonds Zorgverzekeraars
First posted: 2014-11-25
Enrollment: 770
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 5 year overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Disease Free Survival
timeFrame: 5 years
measure: Time to Treatment Failure
timeFrame: 5 years
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Amersfoort
country: Netherlands
facility: Meander MC
city: Assen
country: Netherlands
facility: Wilhelmina Ziekenhuis
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Capelle aan den IJssel
country: Netherlands
facility: IJsselland Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Doetinchem
country: Netherlands
facility: Slingeland Ziekenhuis
city: Drachten
country: Netherlands
facility: NijSmellinghe
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Maxima MC
city: Enschede
country: Netherlands
facility: MST
city: Goes
country: Netherlands
facility: Admiraal de Ruijter Ziekenhuis
city: Gorinchem
country: Netherlands
facility: Beatrix Ziekenhuis
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St. Jansdal
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Leiderdorp
country: Netherlands
facility: Alrijne Ziekenhuis
city: Leidschendam
country: Netherlands
facility: HMC
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis
city: Terneuzen
country: Netherlands
facility: ZorgSaam Zeeuws Vlaanderen
city: The Hague
country: Netherlands
facility: HAGA ziekenhuis
city: Tilburg
country: Netherlands
facility: ETZ
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum
city: Winterswijk
country: Netherlands
facility: Streekziekenhuis Koningin Beatrix (SKB)
city: Zoetermeer
country: Netherlands
facility: Lange Land Ziekenhuis
Study officials:
affiliation: Leiden University Medical Center
name: G.J. Liefers, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Leiden University Medical Center
name: J.E.A. Portielje, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medisch Centrum
name: R. Fodde, Professor
role: PRINCIPAL_INVESTIGATOR
References: