Colorectal CancerPhase 3ALASCCANCT02647099
Adjuvant Low Dose Aspirin in Colorectal Cancer
A Phase 3 study testing Acetylsalicylic acid in people with Colorectal Cancer, run by Anna Martling at 32 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Acetylsalicylic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 626 participants
- Where
- 32 sitesin 4 countries
- Study dates
- 7 Apr 2016to Aug 2026
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 Post-operative treatment with low molecular weight heparin must be withdrawn before administration of study treatment
Show all 16Show fewer
- 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
Trial locations and contacts
32 sites in 4 countries.
32 sites in 4 countries
Sweden23 sites
Falu Hospital
Falun
Eastern Hospital
Gothenburg
Ryhov Hospital
Jönköping
Blekinge Hospital (Karlskrona-Karlshamn)
Karlskrona
Karlstad Central Hospital
Karlstad
Linköping University Hospital
Linköping
Sunderby Hospital
Luleå
Skåne University Hospital
Malmö
Mora Hospital
Mora
Vrinnevi Hospital
Norrköping
Örebro University Hospital
Örebro
Skaraborg Hospital
Skövde
Capio S:t Göran Hospital
Stockholm
Danderyd Hospital
Stockholm
Ersta Hospital
Stockholm
Karolinska University Hospital
Stockholm
South Hospital
Stockholm
Sundsvall Regional Hospital (Sundsvall-Härnösand)
Sundsvall
Northern Älvsborg County Hospital
Trollhättan
University Hospital of Umeå
Umeå
Uppsala University Hospital
Uppsala
Västerås Central Hospital
Västerås
Ystad Hospital
Ystad
Norway4 sites
Akershus University Hospital
Oslo
Stavanger University Hospital
Stavanger
University Hospital of North Norway
Tromsø
St Olavs Hospital
Trondheim
Denmark3 sites
Aarhus University Hospital
Aarhus
Randers Regional Hospital
Randers
Viborg Region Hospital
Viborg
About this study
Official title: A Randomized Double-blind Placebo-controlled Study With ASA Treatment in Colorectal Cancer Patients With Mutations in the PI3K Signaling Pathway
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.
Read the detailed description
Patients with colorectal cancer clinical stage I-III will be screened for inclusion at the time of tumor surgery (at time of routine patient visit before elective surgery or postoperatively within 12 weeks in case of emergency procedure or if screening was missed preoperatively). After inclusion and when surgery is performed, patients with PIK3 mutations and stage II and III tumors will be randomized to receive 160 mg aspirin or placebo orally.
Last date for randomization and start of treatment is 12 weeks postoperatively. The treatment can be administered alone or in combination with adjuvant chemotherapy. The choice of any adjuvant chemotherapy is made by the Investigator and should follow the guidelines in the National Care Program. The treatment will be administered for 3 years. There will be a follow-up period for two years. Outside the trial, the patient will be treated according to standard care at the site.
A phone contact will be made 3 months after the randomization visit and thereafter every 6th month. The patients will also visit the site 6 months after randomization and thereafter every 6th month i.e. the patients will be in contact with the site every 3rd month. There will also be a visit/phone contact at the end of the follow-up period.
The primary objective is to determine whether adjuvant treatment with 160mg ASA once daily for 3 years can improve time to recurrence in participants with colorectal cancer with somatic alternations in the PI3K singling pathway.
UPDATE: New dimensional analysis and power calculation, 19th October 2020:
A total of 3900 patients will be screened in order to include 300 patients with PIK3CA (Exon 9 and 20) mutated tumors in each treatment arm (Group A). With an estimated 10 % drop-out rate, 150 patients will be randomized in each arm. This also includes approximately 15 % of the patients that will be excluded due to tumor stage 1.
An additional 300 patients with mutations in other PI3K pathway genes PIK3CA (other than exon 9 and 20), PIK3R1 or PTEN will also be randomized in each arm and will be treated as a separate group in the analyses (Group B). With an estimated 10 % drop-out rate, 150 patients will be randomized in each arm.
Patients already treated with ASA at inclusion will be included in an observation group.
An interim analysis will be made on safety i.e incidence and type of serious bleeding complication grade > 1 after 12 months. An independent safety data monitoring committee will be responsible for evaluating and follow-up of the safety.
- Conditions
- Colorectal Cancer
- Being tested
- Acetylsalicylic acid, Placebo
- Keywords
- Aspirin, PI3K signaling pathway
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acidDrug
Also called ASA, aspirin
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | One tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years Receives: Drug: Acetylsalicylic acid |
| Placebo | Placebo comparator | One tablet placebo orally once daily for three years Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To Recurrence (TTR)
Number of participants with local recurrence, distant metastases or death from same cancer within 3 years from randomization
Measured: 3 years
Secondary outcomes (3)
Disease Free Survival (DFS)
Number of participants with local recurrence, distant metastases, a new malignant neoplasm, or death from any cause within 3 years from randomization
Measured: 3 years
Overall Survival (OS)
Death from any cause within 5 years from randomization
Measured: 5 years
Frequency and Severity of Adverse Events (AE)
The frequency and severity of severe adverse events in the safety population
Measured: 1 year and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study start7 Apr 2016
- Primary completionAug 2024
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Martling
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital, Skane University Hospital
- Responsible party
- Sponsor-investigator, Anna Martling, Karolinska Institutet
- Investigators
- Anna Martling, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647099
- Sponsor's protocol ID
- 921-2014-7074
- Acronym
- ALASCCA
- Status last verified
- Mar 2026
- First submitted
- 5 Jan 2016
- Last updated
- 13 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 40961426
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Placebo-controlled Study With ASA Treatment in Colorectal Cancer Patients With Mutations in the PI3K Signaling Pathway
- ClinicalTrials.gov ID
- NCT02647099
- Acronym / sponsor ID
- ALASCCA / 921-2014-7074
- Conditions
- Colorectal Cancer
- Keywords
- Aspirin, PI3K signaling pathway
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 626 participants (actual)
- Lead sponsor
- Anna MartlingUniversity, hospital or other
- Collaborators
- Uppsala University Hospital, Skane University Hospital
- Study start
- 7 Apr 2016 (actual)
- Primary completion
- Aug 2024 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Posted 13 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with colorectal cancer clinical stage I-III will be screened for inclusion at the time of tumor surgery (at time of routine patient visit before elective surgery or postoperatively within 12 weeks in case of emergency procedure or if screening was missed preoperatively). After inclusion and when surgery is performed, patients with PIK3 mutations and stage II and III tumors will be randomized to receive 160 mg aspirin or placebo orally.
Last date for randomization and start of treatment is 12 weeks postoperatively. The treatment can be administered alone or in combination with adjuvant chemotherapy. The choice of any adjuvant chemotherapy is made by the Investigator and should follow the guidelines in the National Care Program. The treatment will be administered for 3 years. There will be a follow-up period for two years. Outside the trial, the patient will be treated according to standard care at the site.
A phone contact will be made 3 months after the randomization visit and thereafter every 6th month. The patients will also visit the site 6 months after randomization and thereafter every 6th month i.e. the patients will be in contact with the site every 3rd month. There will also be a visit/phone contact at the end of the follow-up period.
The primary objective is to determine whether adjuvant treatment with 160mg ASA once daily for 3 years can improve time to recurrence in participants with colorectal cancer with somatic alternations in the PI3K singling pathway.
UPDATE: New dimensional analysis and power calculation, 19th October 2020:
A total of 3900 patients will be screened in order to include 300 patients with PIK3CA (Exon 9 and 20) mutated tumors in each treatment arm (Group A). With an estimated 10 % drop-out rate, 150 patients will be randomized in each arm. This also includes approximately 15 % of the patients that will be excluded due to tumor stage 1.
An additional 300 patients with mutations in other PI3K pathway genes PIK3CA (other than exon 9 and 20), PIK3R1 or PTEN will also be randomized in each arm and will be treated as a separate group in the analyses (Group B). With an estimated 10 % drop-out rate, 150 patients will be randomized in each arm.
Patients already treated with ASA at inclusion will be included in an observation group.
An interim analysis will be made on safety i.e incidence and type of serious bleeding complication grade > 1 after 12 months. An independent safety data monitoring committee will be responsible for evaluating and follow-up of the safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: Acetylsalicylic acidOne tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years |
| Placebo | Placebo comparator | Drug: PlaceboOne tablet placebo orally once daily for three years |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic acidAlso: ASA, aspirin | Drug | Aspirin |
| Placebo | Drug | Placebo |
Primary outcome
Time To Recurrence (TTR)
Time frame: 3 years
Number of participants with local recurrence, distant metastases or death from same cancer within 3 years from randomization
3 secondary outcomes
Disease Free Survival (DFS)
Time frame: 3 years
Overall Survival (OS)
Time frame: 5 years
Frequency and Severity of Adverse Events (AE)
Time frame: 1 year and 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40961426Martling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Martling, Professor principal investigator
Karolinska Institutet
32 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylsalicylic acid in people with Colorectal Cancer, run by Anna Martling at 32 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Sweden, Norway, Denmark, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time To Recurrence (TTR) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02647099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.