Trial Outcomes & Findings for Adjuvant Aspirin Treatment for Colon Cancer Patients (NCT NCT02467582)
NCT ID: NCT02467582
Last Updated: 2025-05-16
Results Overview
The primary endpoint of this trial is DFS, defined as time from surgery until one of the following events, whichever comes first: * recurrence * second cancer * death due to any reason Patients not experiencing an event will be censored at the date of the last available tumor assessment.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1040 participants
Primary outcome timeframe
up to 7 years
Results posted on
2025-05-16
Participant Flow
Screened (n=1040) PIK3CA-mutated (n=180) Randomized (n=113) Excluded (n=67): * Not meeting inclusion criteria (n=20) * Declined to participate (n=43) * Other reasons (n=4)
Participant milestones
| Measure |
Aspirin 100 mg
Asprin 100 mg daily for maximum 3 years standard chemo if indicated
Aspirin: Aspirin 100 mg daily
|
Placebo
Placebo daily for maximum 3 years standard chemo if indicated
Placebo: Placebo
|
|---|---|---|
|
Allocation
STARTED
|
75
|
38
|
|
Allocation
COMPLETED
|
74
|
38
|
|
Allocation
NOT COMPLETED
|
1
|
0
|
|
Follow-up
STARTED
|
74
|
38
|
|
Follow-up
COMPLETED
|
63
|
29
|
|
Follow-up
NOT COMPLETED
|
11
|
9
|
Reasons for withdrawal
| Measure |
Aspirin 100 mg
Asprin 100 mg daily for maximum 3 years standard chemo if indicated
Aspirin: Aspirin 100 mg daily
|
Placebo
Placebo daily for maximum 3 years standard chemo if indicated
Placebo: Placebo
|
|---|---|---|
|
Allocation
Withdrawal by Subject
|
1
|
0
|
|
Follow-up
Death
|
5
|
4
|
|
Follow-up
Lost to Follow-up
|
6
|
5
|
Baseline Characteristics
Adjuvant Aspirin Treatment for Colon Cancer Patients
Baseline characteristics by cohort
| Measure |
Aspirin 100 mg
n=74 Participants
Asprin 100 mg daily for maximum 3 years standard chemo if indicated
Aspirin: Aspirin 100 mg daily
|
Placebo
n=38 Participants
Placebo daily for maximum 3 years standard chemo if indicated
Placebo: Placebo
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
43 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
65 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · African
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Caucasian
|
67 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
44 participants
n=5 Participants
|
25 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
25 participants
n=5 Participants
|
11 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 7 yearsThe primary endpoint of this trial is DFS, defined as time from surgery until one of the following events, whichever comes first: * recurrence * second cancer * death due to any reason Patients not experiencing an event will be censored at the date of the last available tumor assessment.
Outcome measures
| Measure |
Aspirin 100 mg
n=74 Participants
Asprin 100 mg daily for maximum 3 years standard chemo if indicated
Aspirin: Aspirin 100 mg daily
|
Placebo
n=38 Participants
Placebo daily for maximum 3 years standard chemo if indicated
Placebo: Placebo
|
|---|---|---|
|
Disease-free Survival (DFS)
|
NA years
Interval 6.19 to
Not reached
|
NA years
Interval 5.77 to
Not reached
|
SECONDARY outcome
Timeframe: up to 7 yearsTTR was calculated from surgery until recurrence or death due to colon cancer. Patients not experiencing an event or patients who died due to other reasons before experiencing an event were censored at the date of the last available tumor assessment.
Outcome measures
| Measure |
Aspirin 100 mg
n=74 Participants
Asprin 100 mg daily for maximum 3 years standard chemo if indicated
Aspirin: Aspirin 100 mg daily
|
Placebo
n=38 Participants
Placebo daily for maximum 3 years standard chemo if indicated
Placebo: Placebo
|
|---|---|---|
|
Time to Recurrence (TTR)
|
NA years
Not reached
|
NA years
Interval 5.77 to
Not reached
|
SECONDARY outcome
Timeframe: up to 7 yearsOS was calculated from surgery until death from any cause. Patients not experiencing an event were censored at the last date they were known to be alive.
Outcome measures
| Measure |
Aspirin 100 mg
n=74 Participants
Asprin 100 mg daily for maximum 3 years standard chemo if indicated
Aspirin: Aspirin 100 mg daily
|
Placebo
n=38 Participants
Placebo daily for maximum 3 years standard chemo if indicated
Placebo: Placebo
|
|---|---|---|
|
Overall Survival (OS)
|
NA years
Not reached
|
NA years
Interval 5.77 to
Not reached
|
SECONDARY outcome
Timeframe: up to 7 yearsCSS was calculated from surgery until death due to colon cancer, whether due to the original tumor or to a second primary same cancer. Patients who died due to other reasons were censored at the time of death. All other patients were censored at the last date they were known to be alive.
Outcome measures
| Measure |
Aspirin 100 mg
n=74 Participants
Asprin 100 mg daily for maximum 3 years standard chemo if indicated
Aspirin: Aspirin 100 mg daily
|
Placebo
n=38 Participants
Placebo daily for maximum 3 years standard chemo if indicated
Placebo: Placebo
|
|---|---|---|
|
Cancer-specific Survival (CSS)
|
NA years
Not reached
|
NA years
Not reached
|
SECONDARY outcome
Timeframe: During treatment (median 22.1 months)Outcome measures
| Measure |
Aspirin 100 mg
n=74 Participants
Asprin 100 mg daily for maximum 3 years standard chemo if indicated
Aspirin: Aspirin 100 mg daily
|
Placebo
n=38 Participants
Placebo daily for maximum 3 years standard chemo if indicated
Placebo: Placebo
|
|---|---|---|
|
Adverse Events (AEs)
Anemia
|
0 Participants
|
1 Participants
|
|
Adverse Events (AEs)
Colonic hemorrhage
|
0 Participants
|
1 Participants
|
|
Adverse Events (AEs)
Cranial fracture with intra cranial hemorrhage
|
0 Participants
|
1 Participants
|
|
Adverse Events (AEs)
Dizziness
|
1 Participants
|
0 Participants
|
Adverse Events
Aspirin 100 mg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 5 deaths
Placebo
Serious events: 3 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Aspirin 100 mg
n=74 participants at risk
Asprin 100 mg daily for maximum 3 years standard chemo if indicated
Aspirin: Aspirin 100 mg daily
|
Placebo
n=38 participants at risk
Placebo daily for maximum 3 years standard chemo if indicated
Placebo: Placebo
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
1.4%
1/74 • Number of events 1 • Deaths were assessed for up to 7 years. Adverse Events were assessed for an median of 22.1 months
|
0.00%
0/38 • Deaths were assessed for up to 7 years. Adverse Events were assessed for an median of 22.1 months
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.00%
0/74 • Deaths were assessed for up to 7 years. Adverse Events were assessed for an median of 22.1 months
|
2.6%
1/38 • Number of events 1 • Deaths were assessed for up to 7 years. Adverse Events were assessed for an median of 22.1 months
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/74 • Deaths were assessed for up to 7 years. Adverse Events were assessed for an median of 22.1 months
|
2.6%
1/38 • Number of events 1 • Deaths were assessed for up to 7 years. Adverse Events were assessed for an median of 22.1 months
|
|
Injury, poisoning and procedural complications
Cranial fracture with intracranial hemorrhage
|
0.00%
0/74 • Deaths were assessed for up to 7 years. Adverse Events were assessed for an median of 22.1 months
|
2.6%
1/38 • Number of events 1 • Deaths were assessed for up to 7 years. Adverse Events were assessed for an median of 22.1 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee SAKK GENERAL TERMS AND CONDITIONS (SAKK GTC) FOR TRIAL SPECIFIC AGREEMENTS
- Publication restrictions are in place
Restriction type: OTHER