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

Colon Cancer Clinical Trial

— ASPIRIN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02301286
• Other study ID #: P14.152
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 770
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adjuvant Therapy
• Colon Cancer
• Colonic Neoplasms
• Recurrence

Intervention

Drug:
• Acetylsalicylic acid

• Placebo Acetylsalicylic acid

Locations

Country	Name	City	State
Netherlands	Ziekenhuisgroep Twente	Almelo
Netherlands	Meander MC	Amersfoort
Netherlands	Wilhelmina Ziekenhuis	Assen
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	IJsselland Ziekenhuis	Capelle aan den IJssel
Netherlands	Reinier de Graaf Gasthuis	Delft
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	Slingeland Ziekenhuis	Doetinchem
Netherlands	NijSmellinghe	Drachten
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Maxima MC	Eindhoven
Netherlands	MST	Enschede
Netherlands	Admiraal de Ruijter Ziekenhuis	Goes
Netherlands	Beatrix Ziekenhuis	Gorinchem
Netherlands	Groene Hart Ziekenhuis	Gouda
Netherlands	Ziekenhuis St. Jansdal	Harderwijk
Netherlands	Elkerliek Ziekenhuis	Helmond
Netherlands	Spaarne Gasthuis	Hoofddorp
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Alrijne Ziekenhuis	Leiderdorp
Netherlands	HMC	Leidschendam
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	Ikazia Ziekenhuis	Rotterdam
Netherlands	Antonius Ziekenhuis	Sneek
Netherlands	ZorgSaam Zeeuws Vlaanderen	Terneuzen
Netherlands	HAGA ziekenhuis	The Hague
Netherlands	ETZ	Tilburg
Netherlands	Diakonessenhuis	Utrecht
Netherlands	VieCuri Medisch Centrum	Venlo
Netherlands	Streekziekenhuis Koningin Beatrix (SKB)	Winterswijk
Netherlands	Lange Land Ziekenhuis	Zoetermeer

Sponsors (6)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5 year overall survival	The time to an event for OS is defined as the time interval between the date of randomisation and the date of death.	5 years
Secondary	Disease Free Survival	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.	5 years
Secondary	Time to Treatment Failure	The time elapsed between randomisation until treatment discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest.	5 years