A Phase 3 interventional study of Acetylsalicylic acid and Placebo in Colorectal Cancer, sponsored by Anna Martling. Active, not recruiting at 32 sites in 4 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by Anna Martling · Phase 3, Interventional, and Treatment
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 626 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Anna Martling is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One tablet acetylsalicylic acid (ASA) 160 mg, orally once daily for three years
Drug: Acetylsalicylic acid
One tablet placebo orally once daily for three years
Drug: Placebo
Also known as: ASA, aspirin
Time To Recurrence (TTR)
Number of participants with local recurrence, distant metastases or death from same cancer within 3 years from randomization
Time frame: 3 years
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
Time frame: 3 years
Overall Survival (OS)
Death from any cause within 5 years from randomization
Time frame: 5 years
Frequency and Severity of Adverse Events (AE)
The frequency and severity of severe adverse events in the safety population
Time frame: 1 year and 3 years
First patient initial screening April 6, 2016. Last patient initial screening April 28, 2021. First patient randomized April 7, 2016. Last patient randomized July 19, 2021.
| Milestone | Aspirin | Placebo |
|---|---|---|
| Started | 313 | 313 |
| Completed | 311 | 312 |
| Not completed | 2 | 1 |
| Withdrew: Lost to follow-up | 2 | 1 |
Number of participants with local recurrence, distant metastases or death from same cancer within 3 years from randomization
| Participants | Aspirin | Placebo |
|---|---|---|
| Time To Recurrence (TTR) | 24 | 50 |
Number of participants with local recurrence, distant metastases, a new malignant neoplasm, or death from any cause within 3 years from randomization
| Participants | Aspirin | Placebo |
|---|---|---|
| Disease Free Survival (DFS) | 38 | 65 |
Death from any cause within 5 years from randomization
Results for this outcome have not been posted.
The frequency and severity of severe adverse events in the safety population
| Participants | Aspirin | Placebo |
|---|---|---|
| Severe adverse events | 52 | 36 |
| Non-severe adverse events | 134 | 110 |
Collected over From the date when a participant first received the study drug until end of follow-up (maximum 3 years from randomization), or until an outcome (recurrence/death), or until the participant dropped out of the trial.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aspirin | 25/309 (8.1%) | 52/309 (16.8%) | 134/309 (43.4%) |
| Placebo | 32/311 (10.3%) | 36/311 (11.6%) | 110/311 (35.4%) |
| Event | Aspirin | Placebo |
|---|---|---|
| IleusGastrointestinal disorders | 11/309 | 2/311 |
| Deep vein thrombosisVascular disorders | 9/309 | 7/311 |
| Pulmonary embolismVascular disorders | 4/309 | 3/311 |
| InjuryInjury, poisoning and procedural complications | 1/309 | 3/311 |
| Covid-19 infectionInfections and infestations | 2/309 | 0/311 |
| Death, unknown causeGeneral disorders | 2/309 | 0/311 |
| Ischemic strokeVascular disorders | 2/309 | 0/311 |
| Parastomal herniaGastrointestinal disorders | 2/309 | 0/311 |
| CholecystitisHepatobiliary disorders | 1/309 | 2/311 |
| Urinary tract infectionInfections and infestations | 1/309 | 2/311 |
| Event | Aspirin | Placebo |
|---|---|---|
| Adverse event of the gastrointestinal organ systemGastrointestinal disorders | 52/309 | 49/311 |
| Adverse event of the hematologic organ systemBlood and lymphatic system disorders | 51/309 | 33/311 |
| Adverse event of the skinSkin and subcutaneous tissue disorders | 20/309 | 18/311 |
| Musculoskeletal and Connective Tissue DisordersMusculoskeletal and connective tissue disorders | 18/309 | 20/311 |
| Age, Categorical(Participants) | Aspirin | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 147 | 140 | 287 |
| >=65 years | 166 | 173 | 339 |
| Sex: Female, Male(Participants) | Aspirin | Placebo | Total |
|---|---|---|---|
| Female | 164 | 160 | 324 |
| Male | 149 | 153 | 302 |
| Race and Ethnicity Not Collected(Participants) | Aspirin | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Aspirin | Placebo | Total |
|---|---|---|---|
| Sweden | 244 | 245 | 489 |
| Norway | 32 | 37 | 69 |
| Denmark | 19 | 14 | 33 |
| Finland | 18 | 17 | 35 |
| Tumour location(Participants) | Aspirin | Placebo | Total |
|---|---|---|---|
| Right colon | 137 | 142 | 279 |
| Left colon | 71 | 66 | 137 |
| Colon (side not specified) | 1 | 2 | 3 |
| Rectum | 104 | 103 | 207 |
| Somatic alteration(Participants) | Aspirin | Placebo | Total |
|---|---|---|---|
| PIK3CA exon 9/20 hotspot mutations | 157 | 157 | 314 |
| Other PI3K alterations | 156 | 156 | 312 |
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This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Anna Martling