Adjuvant Aspirin Treatment for Colon Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02467582|
Recruitment Status : Recruiting
First Posted : June 10, 2015
Last Update Posted : May 27, 2020
Following complete resection of their primary tumor, potentially eligible stage II or stage III colon cancer patients will undergo central PIK3CA testing. Patients with somatic mutations will be 2:1 randomized to daily aspirin 100 mg versus placebo for a total of 3 years or until disease recurrence, patient death or withdrawal of consent, whichever occurs first. Patients will be followed up for 10 years from the date of surgery.
The intake of aspirin or placebo is independent of adjuvant chemotherapy, and does not impact on the indication to give (or not to give) adjuvant chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Drug: Aspirin Drug: Placebo||Phase 3|
Colorectal cancer is the third most common malignancy for both women and men and is responsible for almost 10% of all cancer death. Despite complete removal of the tumor and use of adjuvant chemotherapy, up to 25% of patients with stage II colon cancer and up to 50% of patients with stage III disease will suffer from recurrences, which is associated with poor prognosis.
Several retrospective observations have documented a favorable effect of long-term intake of oral aspirin for the prevention of colorectal cancer in different clinical situations. Regular intake of aspirin after the diagnosis of colorectal cancer may also be associated with a lower risk of colorectal cancer−specific and overall mortality. Two recent publications in prestigious medical journals provided retrospective evidence that patients with PIK3CA-mutated colon cancer may derive a very substantial benefit from daily oral aspirin. Both analyses showed a roughly 85% reduction of the risk for tumor relapse compared to patients who did not take aspirin. However, a potential selection bias in these retrospective analyses cannot be excluded with certainty. These extremely interesting and intriguing findings must be confirmed in a randomized controlled trial to potentially change clinical practice.
The trial objective is to demonstrate a statistically significant and clinically relevant disease-free survival benefit in stage II and III PIK3CA mutated colon cancer patients taking daily adjuvant aspirin for 3 years.
Patients with resected colon cancer stage II or stage III bearing somatic mutations in exon 9 or 20 of PIK3CA will be 2:1 randomized to daily adjuvant aspirin 100 mg versus placebo for a total of 3 years or until disease recurrence, patient death or withdrawal of consent, whichever occurs first. Patients will be followed up for up to 10 years from the date of surgery. The intake of aspirin or placebo is independent of adjuvant chemotherapy, and does not impact on the indication to give (or not to give) adjuvant chemotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||185 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Adjuvant Aspirin Treatment in PIK3CA Mutated Colon Cancer Patients. A Randomized, Double-blinded, Placebo-controlled, Phase III Trial|
|Actual Study Start Date :||June 9, 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||June 2029|
Experimental: Aspirin 100 mg
Asprin 100 mg daily for 3 years standard chemo if indicated
Aspirin 100 mg daily
Other Name: acetylsalicylic acid
Active Comparator: Placebo
Placebo daily for 3 years standard chemo if indicated
- Disease-free survival (DFS) [ Time Frame: at 6 years after first patient in. ]
- Time to recurrence (TTR) [ Time Frame: at 6 years after first patient in. ]
- Overall survival (OS) [ Time Frame: at 6 years after first patient in and trial termination (13 years after first patient in) ]
- Cancer-specific survival (CSS) [ Time Frame: at 6 years after first patient in and trial termination (13 years after first patient in). ]
- Adverse events (AEs) [ Time Frame: at 6 years after first patient in. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467582
|Contact: Karin Rotgiesser, PhD||+41 31 389 91 firstname.lastname@example.org|
|Study Chair:||Ulrich Güller, Prof||Cantonal Hospital of St. Gallen|