Clinical trial · Interventional
Low-dose Aspirin Therapy for Esophageal Cancer
Low-dose Aspirin Therapy for Stage II-III Esophageal Cancer- A Multi-Center, Open Label, Randomized Controlled Phase III Trial
NCT02326779CI-TRIAL-00051483withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study could not be performed.
Summary
Brief summary (as posted)
The aim of this study is to evaluate the survival benefit of low-dose aspirin use for stage II-III esophageal cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetylsalicylic acid | Drug | Aspirin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- Experimental Arm: acetylsalicylic acid (Aspirin) 100 mg OD for 3 years
- interventionNames
- Drug: Acetylsalicylic acid
- type
- NO_INTERVENTION
- label
- Comparator Arm
- description
- Non-aspirin use arm as comparator
Primary outcomes (2)
- measure
- Disease-free survival
- timeFrame
- 5 years
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female subjects with an age of 18 years or older. 2. Subjects with Stage II-III histological proven esophageal cancer. 3. Subjects with performance status (PS) of 0-1 or ECOG performance status 0-2. 4. Subjects must have signed an approved informed consent prior to any study procedures. 5. 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; 6. Subjects undergone complete resection of primary tumor; 7. Subjects with life expectancy ≥ 3 months. 8. Completed standard therapy ( at least 3 months of chemotherapy ± radiotherapy ) 9. Within 120 days of completion of standard therapy (surgery, chemotherapy ± radiotherapy) Exclusion Criteria: 1. Subjects with haemorrhagic diathesis (i.e. haemophilia). 2. Subjects with prior malignant tumors except for esophageal cancers in the past 5 years. 3. Subjects with documented or suspected central nervous system metastases. 4. Subjects with serious, nonhealing wound, ulcer, or bone fracture. 5. Subjects with a history of stroke, coronary arterial disease, angina, or vascular disease. 6. Subjects who are pregnant, lactating, or not using adequate contraception. 7. Subjects who have known allergy to NSAID or Aspirin. 8. Subjects receiving other antiplatelet agents (i.e. clopidogrel, ticlopidine) or anticoagulants (i.e. warfarin, low molecular weight heparins). 9. Subjects receiving current long term treatment (≥ 1 month) with Aspirin or other NSAIDs. 10. Subject unwilling or unable to comply with study requirements.
References
Publications (0)
Data not yet available
No reference posted for this study.