Colon CancerPhase 3ASPIRINNCT02301286

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

A Phase 3 study testing Acetylsalicylic acid in people with Colon Cancer and Adjuvant Therapy, run by Leiden University at 32 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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

Who is it for?: Ages 45 years and older
Conditions the study is for: Colon Cancer, Adjuvant Therapy
What is being tested?: Acetylsalicylic acid
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 770 participants
Where: 32 sitesNetherlands
Study dates: Jan 2015to Dec 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 10Show fewer

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

Trial locations and contacts

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

Netherlands32 sites

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

Other trials in Netherlands

About this study

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

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

Read the 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.

Conditions: Colon Cancer, Adjuvant Therapy
Being tested: Acetylsalicylic acid, Placebo Acetylsalicylic acid
Keywords: Acetylsalicylic acid, Colon cancer, Survival
Medical subject headings: Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acetylsalicylic acidDrug
Also called Aspirin
Placebo Acetylsalicylic acidDrug
Also called Placebo

Study groups in NCT02301286
Study group	Role	What they receive
Aspirin	Experimental	Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy. Receives: Drug: Acetylsalicylic acid
Placebo	Placebo comparator	Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy. Receives: Drug: Placebo Acetylsalicylic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 5 years

Secondary outcomes (2)

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.
Measured: 5 years
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.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Dec 2027

First posted25 Nov 2014 (estimated)
Study startJan 2015
Primary completionDec 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Colon CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 770 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02301286
Sponsor's protocol ID: P14.152
Acronym: ASPIRIN
Status last verified: Mar 2024
First submitted: 7 Nov 2014
Last updated: 18 Mar 2024
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
ClinicalTrials.gov ID: NCT02301286
Acronym / sponsor ID: ASPIRIN / P14.152
Conditions: Colon Cancer, Adjuvant Therapy
Keywords: Acetylsalicylic acid, Colon cancer, Survival
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 770 participants (actual)
Lead sponsor: Leiden UniversityUniversity, hospital or other
Collaborators: Stichting voor Patienten met Kanker aan het Spijsverteringskanaal (SPKS), Dutch Colorectal Cancer Group, Stichting Geriatrische Oncologie Nederland (GeriOnNe), Fonds NutsOhra, Innovatiefonds Zorgverzekeraars
Study start: Jan 2015 (actual)
Primary completion: Dec 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 25 Nov 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Aspirin	Experimental	Drug: Acetylsalicylic acidPatients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.
Placebo	Placebo comparator	Drug: Placebo Acetylsalicylic acidPatients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (10 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acetylsalicylic acidAlso: Aspirin	Drug	Aspirin
Placebo Acetylsalicylic acidAlso: Placebo	Drug	Placebo

Primary outcome

5 year overall survival
Time frame: 5 years
The time to an event for OS is defined as the time interval between the date of randomisation and the date of death.

2 secondary outcomes

Disease Free Survival
Time frame: 5 years
Time to Treatment Failure
Time frame: 5 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

G.J. Liefers, MD PhD principal investigator

Leiden University Medical Center

J.E.A. Portielje, Professor principal investigator

Leiden University Medical Center

R. Fodde, Professor principal investigator

Erasmus Medisch Centrum

32 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Acetylsalicylic acid in people with Colon Cancer and Adjuvant Therapy, run by Leiden University at 32 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5 year overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02301286.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.