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

Primary Purpose

Colon Cancer, Adjuvant Therapy

Status
Active
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Acetylsalicylic acid
Placebo Acetylsalicylic acid
Sponsored by
Leiden University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Acetylsalicylic acid, Colon cancer, Survival

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuisgroep Twente
  • Meander MC
  • Wilhelmina Ziekenhuis
  • Amphia Ziekenhuis
  • IJsselland Ziekenhuis
  • Reinier de Graaf Gasthuis
  • Deventer Ziekenhuis
  • Slingeland Ziekenhuis
  • NijSmellinghe
  • Ziekenhuis Gelderse Vallei
  • Catharina Ziekenhuis
  • Maxima MC
  • MST
  • Admiraal de Ruijter Ziekenhuis
  • Beatrix Ziekenhuis
  • Groene Hart Ziekenhuis
  • Ziekenhuis St. Jansdal
  • Elkerliek Ziekenhuis
  • Spaarne Gasthuis
  • Leiden University Medical Center
  • Alrijne Ziekenhuis
  • HMC
  • St. Antonius Ziekenhuis
  • Ikazia Ziekenhuis
  • Antonius Ziekenhuis
  • ZorgSaam Zeeuws Vlaanderen
  • HAGA ziekenhuis
  • ETZ
  • Diakonessenhuis
  • VieCuri Medisch Centrum
  • Streekziekenhuis Koningin Beatrix (SKB)
  • Lange Land Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aspirin

Placebo

Arm Description

Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 7, 2014
Last Updated
March 10, 2023
Sponsor
Leiden University
Collaborators
Stichting voor Patienten met Kanker aan het Spijsverteringskanaal (SPKS), Dutch Colorectal Cancer Group, Stichting Geriatrische Oncologie Nederland (GeriOnNe), Fonds NutsOhra, Innovatiefonds Zorgverzekeraars
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1. Study Identification

Unique Protocol Identification Number
NCT02301286
Brief Title
A Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
Acronym
ASPIRIN
Official Title
A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University
Collaborators
Stichting voor Patienten met Kanker aan het Spijsverteringskanaal (SPKS), Dutch Colorectal Cancer Group, Stichting Geriatrische Oncologie Nederland (GeriOnNe), Fonds NutsOhra, Innovatiefonds Zorgverzekeraars

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Adjuvant Therapy
Keywords
Acetylsalicylic acid, Colon cancer, Survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
770 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspirin
Arm Type
Experimental
Arm 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 Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic acid
Other Intervention Name(s)
Aspirin
Intervention Type
Drug
Intervention Name(s)
Placebo Acetylsalicylic acid
Other Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
5 year overall survival
Description
The time to an event for OS is defined as the time interval between the date of randomisation and the date of death.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Disease Free Survival
Description
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.
Time Frame
5 years
Title
Time to Treatment Failure
Description
The time elapsed between randomisation until treatment discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G.J. Liefers, MD PhD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J.E.A. Portielje, Professor
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
R. Fodde, Professor
Organizational Affiliation
Erasmus Medisch Centrum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuisgroep Twente
City
Almelo
Country
Netherlands
Facility Name
Meander MC
City
Amersfoort
Country
Netherlands
Facility Name
Wilhelmina Ziekenhuis
City
Assen
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Facility Name
IJsselland Ziekenhuis
City
Capelle aan den IJssel
Country
Netherlands
Facility Name
Reinier de Graaf Gasthuis
City
Delft
Country
Netherlands
Facility Name
Deventer Ziekenhuis
City
Deventer
Country
Netherlands
Facility Name
Slingeland Ziekenhuis
City
Doetinchem
Country
Netherlands
Facility Name
NijSmellinghe
City
Drachten
Country
Netherlands
Facility Name
Ziekenhuis Gelderse Vallei
City
Ede
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
Maxima MC
City
Eindhoven
Country
Netherlands
Facility Name
MST
City
Enschede
Country
Netherlands
Facility Name
Admiraal de Ruijter Ziekenhuis
City
Goes
Country
Netherlands
Facility Name
Beatrix Ziekenhuis
City
Gorinchem
Country
Netherlands
Facility Name
Groene Hart Ziekenhuis
City
Gouda
Country
Netherlands
Facility Name
Ziekenhuis St. Jansdal
City
Harderwijk
Country
Netherlands
Facility Name
Elkerliek Ziekenhuis
City
Helmond
Country
Netherlands
Facility Name
Spaarne Gasthuis
City
Hoofddorp
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands
Facility Name
Alrijne Ziekenhuis
City
Leiderdorp
Country
Netherlands
Facility Name
HMC
City
Leidschendam
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Ikazia Ziekenhuis
City
Rotterdam
Country
Netherlands
Facility Name
Antonius Ziekenhuis
City
Sneek
Country
Netherlands
Facility Name
ZorgSaam Zeeuws Vlaanderen
City
Terneuzen
Country
Netherlands
Facility Name
HAGA ziekenhuis
City
The Hague
Country
Netherlands
Facility Name
ETZ
City
Tilburg
Country
Netherlands
Facility Name
Diakonessenhuis
City
Utrecht
Country
Netherlands
Facility Name
VieCuri Medisch Centrum
City
Venlo
Country
Netherlands
Facility Name
Streekziekenhuis Koningin Beatrix (SKB)
City
Winterswijk
Country
Netherlands
Facility Name
Lange Land Ziekenhuis
City
Zoetermeer
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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