Low-dose Aspirin Therapy for Esophageal Cancer

Study Overview
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Brief Summary
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The aim of this study is to evaluate the survival benefit of low-dose aspirin use for stage II-III esophageal cancer patients.

Detailed Description
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The investigators aimed to evaluate the hypothesis that low-dose aspirin can improve survival in stage II-III esophageal cancer patients, and to evaluate whether this effect is influenced by PIK3CA, KRAS, BRAF mutation and COX-2 expression. Eligible participants will be randomized to either aspirin treatment arm (100 mg aspirin OD for 3 years), or non-aspirin user arm in 1:1 ratio. After randomization, participants will receive 3 monthly assessments during treatment and follow-up.

Official Title
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Low-dose Aspirin Therapy for Stage II-III Esophageal Cancer- A Multi-Center, Open Label, Randomized Controlled Phase III Trial

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: Acetylsalicylic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects with an age of 18 years or older. Subjects with Stage II-III histological proven esophageal cancer. Subjects with performance status (PS) of 0-1 or ECOG performance status 0-2. Subjects must have signed an approved informed consent prior to any study procedures. Subjects with adequate bone marrow, hepatic and renal functions, with a) neutrophils ≥ 1.5x109/ L; platelets ≥ 100x109/L; hemoglobin ≥ 9g/dL; b) Total bilirubin ≤ 2.0 x the upper limit normal; ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN in case of liver metastasis); c) creatinine clearance > 50 ml/min; Subjects undergone complete resection of primary tumor; Subjects with life expectancy ≥ 3 months. Completed standard therapy ( at least 3 months of chemotherapy ± radiotherapy ) Within 120 days of completion of standard therapy (surgery, chemotherapy ± radiotherapy) Exclusion Criteria: Subjects with haemorrhagic diathesis (i.e. haemophilia). Subjects with prior malignant tumors except for esophageal cancers in the past 5 years. Subjects with documented or suspected central nervous system metastases. Subjects with serious, nonhealing wound, ulcer, or bone fracture. Subjects with a history of stroke, coronary arterial disease, angina, or vascular disease. Subjects who are pregnant, lactating, or not using adequate contraception. Subjects who have known allergy to NSAID or Aspirin. Subjects receiving other antiplatelet agents (i.e. clopidogrel, ticlopidine) or anticoagulants (i.e. warfarin, low molecular weight heparins). Subjects receiving current long term treatment (≥ 1 month) with Aspirin or other NSAIDs. Subject unwilling or unable to comply with study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br>Experimental Arm: acetylsalicylic acid (Aspirin) 100 mg OD for 3 years | Drug: Acetylsalicylic acid<br>* Acetylsalicylic acid (Aspirin) 100 mg OD for 3 years<br>* Other names: Aspirin;|
| No Intervention: Comparator Arm<br>Non-aspirin use arm as comparator | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 5 years | 
| Overall survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal cancer, aspirin, survival