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

Phase 3

Active, not recruiting

Conditions: Patients with resected colon carcinoma

Registration Number: 2022-502798-40-00

Lead Sponsor: Antwerp University Hospital

Brief Summary: To study 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruitment ended

Sex: Not specified

Target Recruitment: 400

Inclusion Criteria

Patients 45 years and older

Patients with histologically confirmed adenocarcinoma of the colon

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: more advanced tumour is stage II or III)

Patients who have undergone curative radical resection (R0 resection) within 12 weeks prior to study entry

Written informed consent according to national and local regulation

Exclusion Criteria

Patients with rectal cancer (defined as tumour within 15 cm from the anal verge)

Previous malignancies other than CIN, BCC or SCC with a disease free survival less than 5 years

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

Patients currently taking (low-dose) acetylsalicylic acid or other anti-aggregantia for any reason

Patients currently taking oral anti-coagulants or use of LMWH or use of DOACs

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 or equivalent)

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 (father/mother/brother/sister/son/daughter)

Allergy or intolerance to salicylates

Patients with local or distant recurrent disease

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is 5 year Overall Survival (5y-OS). The time to an event for OS is defined as the time interval between the date of randomisation and the date of death. A patient that is still alive at the last date of follow-up patient is censored for analysis and the time at risk corresponds to the time interval between the date of randomisation and the date of last follow up.		The primary endpoint is 5 year Overall Survival (5y-OS). The time to an event for OS is defined as the time interval between the date of randomisation and the date of death. A patient that is still alive at the last date of follow-up patient is censored for analysis and the time at risk corresponds to the time interval between the date of randomisation and the date of last follow up.

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival (DFS). 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. The date of radiological evidence, e.g. CT, MRI, etc, or colonoscopy will be considered as date of recurrence.		Disease Free Survival (DFS). 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. The date of radiological evidence, e.g. CT, MRI, etc, or colonoscopy will be considered as date of recurrence.
Time to Treatment Failure (TTF). The time elapsed between randomisation until treatment discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest.		Time to Treatment Failure (TTF). The time elapsed between randomisation until treatment discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest.

Trial Locations

Locations (29): Jessa Ziekenhuis
🇧🇪
Hasselt, Belgium
AZ Glorieux
🇧🇪
Ronse, Belgium
CHU Ambroise Pare
🇧🇪
Mons, Belgium
Sint-Lucas General Hospital
🇧🇪
Brugge, Belgium
Grand Hopital De Charleroi
🇧🇪
Charleroi, Belgium
AZ Rivierenland campus Rumst
🇧🇪
Reet, Belgium
Sint-Dimpna Ziekenhuis Geel
🇧🇪
Geel, Belgium
Chirec
🇧🇪
Brussels, Belgium
Centre Hospitalier de Mouscron
🇧🇪
Mouscron, Belgium
CHU UCL Namur
🇧🇪
Namur, Belgium
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Jessa Ziekenhuis
🇧🇪Hasselt, Belgium
Daan Walgraeve
Site contact
+3211289730
daan.walgraeve@jessazh.be