Adjuvant Low Dose Aspirin in Colorectal Cancer
ALASCCA
A Randomized Double-blind Placebo-controlled Study With ASA Treatment in Colorectal Cancer Patients With Mutations in the PI3K Signaling Pathway
1 other identifier
interventional
626
4 countries
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 colorectal-cancer
Started Apr 2016
Longer than P75 for phase_3 colorectal-cancer
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2016
CompletedFirst Posted
Study publicly available on registry
January 6, 2016
CompletedStudy Start
First participant enrolled
April 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedResults Posted
Study results publicly available
March 13, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedMarch 13, 2026
March 1, 2026
8.3 years
January 5, 2016
February 18, 2026
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time To Recurrence (TTR)
Number of participants with local recurrence, distant metastases or death from same cancer within 3 years from randomization
3 years
Secondary Outcomes (3)
Disease Free Survival (DFS)
3 years
Overall Survival (OS)
5 years
Frequency and Severity of Adverse Events (AE)
1 year and 3 years
Study Arms (2)
Aspirin
ACTIVE COMPARATOROne tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years
Placebo
PLACEBO COMPARATOROne tablet placebo orally once daily for three years
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anna Martlinglead
- Uppsala University Hospitalcollaborator
- Skane University Hospitalcollaborator
Study Sites (32)
Aarhus University Hospital
Aarhus, Denmark
Randers Regional Hospital
Randers, Denmark
Viborg Region Hospital
Viborg, Denmark
Jorvi Hospital
Espoo, Finland
Meilahti Tower Hospital
Helsinki, Finland
Akershus University Hospital
Oslo, Norway
Stavanger University Hospital
Stavanger, Norway
University Hospital of North Norway
Tromsø, Norway
St Olavs Hospital
Trondheim, Norway
Falu Hospital
Falun, Sweden
Eastern Hospital
Gothenburg, Sweden
Ryhov Hospital
Jönköping, Sweden
Blekinge Hospital (Karlskrona-Karlshamn)
Karlskrona, Sweden
Karlstad Central Hospital
Karlstad, Sweden
Linköping University Hospital
Linköping, Sweden
Sunderby Hospital
Luleå, Sweden
Skåne University Hospital
Malmo, Sweden
Mora Hospital
Mora, Sweden
Vrinnevi Hospital
Norrköping, Sweden
Örebro University Hospital
Örebro, Sweden
Skaraborg Hospital
Skövde, Sweden
Capio S:t Göran Hospital
Stockholm, Sweden
Danderyd Hospital
Stockholm, Sweden
Ersta Hospital
Stockholm, Sweden
Karolinska University Hospital
Stockholm, Sweden
South Hospital
Stockholm, Sweden
Sundsvall Regional Hospital (Sundsvall-Härnösand)
Sundsvall, Sweden
Northern Älvsborg County Hospital
Trollhättan, Sweden
University Hospital of Umeå
Umeå, Sweden
Uppsala University Hospital
Uppsala, Sweden
Västerås Central Hospital
Västerås, Sweden
Ystad Hospital
Ystad, Sweden
Related Publications (1)
Martling 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: 40961426DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anna Martling
- Organization
- Karolinska Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Martling, Professor
Karolinska Institutet
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 5, 2016
First Posted
January 6, 2016
Study Start
April 7, 2016
Primary Completion
August 1, 2024
Study Completion (Estimated)
August 1, 2026
Last Updated
March 13, 2026
Results First Posted
March 13, 2026
Record last verified: 2026-03