Low-dose Aspirin Therapy for Esophageal Cancer

NCT ID: NCT02326779

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-12-31

Brief Summary

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

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm

Experimental Arm: acetylsalicylic acid (Aspirin) 100 mg OD for 3 years

Group Type: EXPERIMENTAL

Acetylsalicylic acid

Intervention Type: DRUG

Acetylsalicylic acid (Aspirin) 100 mg OD for 3 years

Comparator Arm

Non-aspirin use arm as comparator

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acetylsalicylic acid

Acetylsalicylic acid (Aspirin) 100 mg OD for 3 years

Intervention Type: DRUG

Other Intervention Names

Aspirin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Yihua, Wu

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

NNSFC 81302455

Identifier Type: -

Identifier Source: org_study_id