Overview

Low-dose Aspirin Therapy for Esophageal Cancer

Status:
Withdrawn

Trial end date:
2018-12-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Zhejiang University

Treatments:

Aspirin

Criteria

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.