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

Sponsors

Lead Sponsor: Leiden University Medical Center

Collaborator: Stichting voor Patienten met Kanker aan het Spijsverteringskanaal (SPKS)
Dutch Colorectal Cancer Group
Stichting Geriatrische Oncologie Nederland (GeriOnNe)
Fonds NutsOhra
Innovatiefonds Zorgverzekeraars

Source 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.

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 January 2015
Completion Date September 2022
Primary Completion Date September 2022
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
Condition
Intervention

Intervention Type: Drug

Intervention Name: Acetylsalicylic acid

Arm Group Label: Aspirin

Other Name: Aspirin

Intervention Type: Drug

Intervention Name: Placebo Acetylsalicylic acid

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
Overall Contact

Last Name: J.P.B.M. Braak

Phone: 0031715263500

Email: [email protected]

Location
Facility: Status: Contact:
Ziekenhuisgroep Twente | Almelo, Netherlands Recruiting E.A. Kouwenhoven, MD PhD
Meander MC | Amersfoort, Netherlands Recruiting E.C.J. Consten, MD Phd
Wilhelmina Ziekenhuis | Assen, Netherlands Recruiting P. Nieboer, MD PhD
Amphia Ziekenhuis | Breda, Netherlands Recruiting O.J.L. Loosveld, MD
IJsselland Ziekenhuis | Capelle aan den IJssel, Netherlands Recruiting D.F.S. Kehrer, MD Phd
Reinier de Graaf Gasthuis | Delft, Netherlands Recruiting J.W.T. Dekker, MD Phd
Deventer Ziekenhuis | Deventer, Netherlands Recruiting L.W. Kessels, MD
Slingeland Ziekenhuis | Doetinchem, Netherlands Recruiting C. Van Arkel, MD PhD
NijSmellinghe | Drachten, Netherlands Recruiting H. Van Der Mijle, MD PhD
Ziekenhuis Gelderse Vallei | Ede, Netherlands Recruiting A. Baars, MD PhD
Catharina Ziekenhuis | Eindhoven, Netherlands Recruiting G.J. Creemers, MD PhD
Maxima MC | Eindhoven, Netherlands Recruiting G.D. Slooter, MD Phd
MST | Enschede, Netherlands Recruiting E.B. Van Duyn, MD
Admiraal de Ruijter Ziekenhuis | Goes, Netherlands Recruiting H.K. Halteren, MD
Beatrix Ziekenhuis | Gorinchem, Netherlands Recruiting M. Davidis, MD
Groene Hart Ziekenhuis | Gouda, Netherlands Recruiting C.I.M. Baeten, MD PhD
Kennemer Gasthuis | Haarlem, Netherlands Recruiting H.B.A.C. Stockmann, MD PhD
Ziekenhuis St. Jansdal | Harderwijk, Netherlands Recruiting M. Temizkan, MD
Elkerliek Ziekenhuis | Helmond, Netherlands Recruiting J. Vincent, MD
Spaarne Ziekenhuis | Hoofddorp, Netherlands Recruiting B. De Valk, MD PhD
Leiden University Medical Center | Leiden, Netherlands Recruiting G.J. Liefers, MD PhD
Alrijne Ziekenhuis | Leiderdorp, Netherlands Recruiting P.A. Neijenhuis, MD
HMC | Leidschendam, Netherlands Recruiting A.W.K.S. Marinelli, MD PhD
MC Zuiderzee | Lelystad, Netherlands Recruiting R.M. Smeenk, MD PhD
St. Antonius Ziekenhuis | Nieuwegein, Netherlands Recruiting M. Los, MD PhD
Ikazia Ziekenhuis | Rotterdam, Netherlands Recruiting B. Toorenvliet, MD PhD
Antonius Ziekenhuis | Sneek, Netherlands Recruiting G.J. Veldhuis, MD PhD
ZorgSaam Zeeuws Vlaanderen | Terneuzen, Netherlands Recruiting M. Van Dijk, MD PhD
HAGA ziekenhuis | The Hague, Netherlands Recruiting J.E.A. Portielje, MD PhD
ETZ | Tilburg, Netherlands Recruiting R.J. Van Alphen, MD
Diakonessenhuis | Utrecht, Netherlands Recruiting D. ten Bokkel Huinink, MD PhD
VieCuri Medisch Centrum | Venlo, Netherlands Recruiting A.J. Van De Wouw, MD PhD
Streekziekenhuis Koningin Beatrix (SKB) | Winterswijk, Netherlands Recruiting P.P.J.B.M. Schiphorst, MD PhD
Lange Land Ziekenhuis | Zoetermeer, Netherlands Recruiting A.J.M. Van der Pas, MD PhD
Location Countries

Netherlands

Verification Date

February 2020

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
Arm Group

Label: Aspirin

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.

Label: Placebo

Type: Placebo Comparator

Description: Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.

Acronym ASPIRIN
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov