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ALASCCA-A randomized double-blind placebo-controlled study with ASA treatment in colorectal cancer patients with mutations in the PI3K signaling pathway
EU CTIS ID: 2024-513778-23-00
What this study is testing
To determine whether adjuvant treatment with 160 mg Acetylsalicylic Acid (ASA) once daily for 3 years can improve Time To Recurrence (TTR) in patients with colorectal cancer with somatic alterations in the PIK3CA (exon 9 and 20), compared with placebo.
- 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
- - Tumor with somatic alterations in PIK3CA, PIK3R1 or PTEN
- - Colon cancer tumor stage II-III or rectal cancer tumor stage I-III
- - Patient between18-80 years (including)
- - Radical surgery according to surgeon and pathologist
- - Karnofsky performance status ≥60%
- - Platelets ≥ 100 x 109 / L
You likely can't join if
- - Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome - Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- - Existing renal failure according to Investigator’s judgment. Renal failure with decreased creatinine clearance <60 should lead to consultation with a nephrologist.
- - Significant medical illness that would interfere with study participation
- - Pregnancy or breastfeeding females
- - Known allergy to NSAIDs or ASA
- - Current participation in another clinical trial that will be in conflict with the present study
See the full eligibility criteria
- - Tumor with somatic alterations in PIK3CA, PIK3R1 or PTEN
- - Colon cancer tumor stage II-III or rectal cancer tumor stage I-III
- - Patient between18-80 years (including)
- - Radical surgery according to surgeon and pathologist
- - Karnofsky performance status ≥60%
- - Platelets ≥ 100 x 109 / L
- - Clean Colonoscopy or Computed Tomography (CT) colon within 3 months preoperatively or postoperatively but before randomization
- - Patient able to swallow tablets
- - Patient able to understand and sign written informed consent
- - Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome - Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- - Existing renal failure according to Investigator’s judgment. Renal failure with decreased creatinine clearance <60 should lead to consultation with a nephrologist.
- - Significant medical illness that would interfere with study participation
- - Pregnancy or breastfeeding females
- - Known allergy to NSAIDs or ASA
- - Current participation in another clinical trial that will be in conflict with the present study
- - Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study
- - Distant metastases
- - Other cancers (excluding colorectal cancer or other skin cancer than melanoma) within 3 years from screening
- - Known bleeding diathesis (such as hemophilia)
- - Concomitant antiplatelet therapy (eg clopidrogrel or ticlopidine) or anticoagulant therapy (warfarin or low molecular weight heparin). Post-operative treatment with low molecular weight heparin must be withdrawn before administration of study treatment
- - Active gastritis or peptic ulcer, or significant surgical post-op bleeding, within the previous three months assessed at screening and randomization
- - Ongoing regular use of corticosteroids, Nonsteroidal Anti-Inflammatory Drug (NSAID)
- - Uncontrolled hypertension according to Investigator’s judgment
- - Clinically significant liver impairment according to Investigators judgment
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.