Clinical trial · Interventional
Adjuvant Low Dose Aspirin in Colorectal Cancer
A Randomized Double-blind Placebo-controlled Study With ASA Treatment in Colorectal Cancer Patients With Mutations in the PI3K Signaling Pathway
NCT02647099CI-TRIAL-00105480ALASCCAactive not recruitingPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
ALASCCA is a randomized, parallel group, double blind, multicenter, placebo-controlled, biomarker-based study of adjuvant treatment with low dose aspirin in patients with colorectal cancer. Hypothesis is that patients diagnosed with colorectal cancer and somatic mutations in PI3K pathway can significantly improve survival if treated with low dose aspirin.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetylsalicylic acid | Drug | Aspirin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Aspirin
- description
- One tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years
- interventionNames
- Drug: Acetylsalicylic acid
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- One tablet placebo orally once daily for three years
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Time To Recurrence (TTR)
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Tumor with somatic alterations in PIK3CA, PIK3R1 or PTEN * Colon or rectal cancer tumor stage II-III * 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 Exclusion Criteria: * Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome * Inflammatory bowel disease (Crohn's disease or ulcerative colitis) * 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 * 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
References
Publications (1)
- DERIVEDMartling A, Hed Myrberg I, Nilbert M, Gronberg H, Granath F, Eklund M, Oresland T, Iversen LH, Haapamaki C, Janson M, Westberg K, Segelman J, Ersson U, Prytz M, Angenete E, Bergstrom R, Mayrhofer M, Glimelius B, Lindberg J; ALASCCA Study Group. Low-Dose Aspirin for PI3K-Altered Localized Colorectal Cancer. N Engl J Med. 2025 Sep 18;393(11):1051-1064. doi: 10.1056/NEJMoa2504650. PMID 40961426