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NCT02301286Active, not recruitingPhase 3

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

A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients

Source: ClinicalTrials.gov · Last updated 18 Mar 2024

Brief summary (registry, in English)

The purpose of this study is to determine whether acetylsalicylic acidis effective on the recurrence and survival of colon cancer patients.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
770 (actual)
First submitted
7 Nov 2014
Start date
Jan 2015
Primary completion date
Dec 2027
Lead sponsor
Leiden University
NCT number
NCT02301286

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 770
  • From Jan 2015 to the primary completion date, Dec 2027
  • 32 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients currently taking oral anti-coagulants or use of LMWH
  • Patients currently taking acetylsalicylic acid for any reason
  • Patients currently taking high dose systemic glucocorticoids.(≥ 30 mg predniso(lo)n)

Other illness

  • Patients with rectal cancer (defined as tumour within 15 cm from the anal verge)
  • Patients with a history of bleeding disorders or active gastric or duodenal ulcers
  • 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

Who the study is looking for

  • 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

Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ziekenhuisgroep Twente
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AlmeloNetherlandsUnknown status
Meander MC
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AmersfoortNetherlandsUnknown status
Wilhelmina ziekenhuis
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AssenNetherlandsUnknown status
Amphia Ziekenhuis
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BredaNetherlandsUnknown status
IJsselland Ziekenhuis
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Capelle aan den IJsselNetherlandsUnknown status
Reinier de Graaf Gasthuis
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DelftNetherlandsUnknown status
Deventer Ziekenhuis
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DeventerNetherlandsUnknown status
Slingeland Ziekenhuis
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DoetinchemNetherlandsUnknown status
NijSmellinghe
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DrachtenNetherlandsUnknown status
Ziekenhuis Gelderse Vallei
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EdeNetherlandsUnknown status
Catharina Ziekenhuis
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EindhovenNetherlandsUnknown status
Máxima MC
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EindhovenNetherlandsUnknown status
MST
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EnschedeNetherlandsUnknown status
Admiraal de Ruijter Ziekenhuis
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GoesNetherlandsUnknown status
Beatrix Ziekenhuis
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GorinchemNetherlandsUnknown status
Groene Hart Ziekenhuis
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GoudaNetherlandsUnknown status
Ziekenhuis St Jansdal
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HarderwijkNetherlandsUnknown status
Elkerliek ziekenhuis
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HelmondNetherlandsUnknown status
Spaarne Gasthuis
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HoofddorpNetherlandsUnknown status
Leiden University Medical Center
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LeidenNetherlandsUnknown status
Alrijne Ziekenhuis
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LeiderdorpNetherlandsUnknown status
HMC
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LeidschendamNetherlandsUnknown status
St. Antonius Ziekenhuis
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NieuwegeinNetherlandsUnknown status
Ikazia Ziekenhuis
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RotterdamNetherlandsUnknown status
Antonius Ziekenhuis
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SneekNetherlandsUnknown status
ZorgSaam Zeeuws Vlaanderen
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TerneuzenNetherlandsUnknown status
Haga Ziekenhuis
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The HagueNetherlandsUnknown status
ETZ
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TilburgNetherlandsUnknown status
Diakonessenhuis
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UtrechtNetherlandsUnknown status
VieCuri Medisch Centrum
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VenloNetherlandsUnknown status
Streekziekenhuis Koningin Beatrix (SKB)
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WinterswijkNetherlandsUnknown status
Lange Land Ziekenhuis
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ZoetermeerNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.