BridgeMD
A Phase III double-blind placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
EU CTIS ID: 2022-502324-48-00
What this study is testing
To study 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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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) (TNM version 7)
- 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
You likely can't join if
- 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
See the full eligibility 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) (TNM version 7)
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.