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

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

Study Overview

• Status: Withdrawn
• Conditions: Esophageal Cancer
• Intervention / Treatment: Drug: Acetylsalicylic acid

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.

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	5 years

Collaborators and Investigators

• Sponsor: Zhejiang University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 22, 2014
• First Submitted That Met QC Criteria: December 26, 2014
• First Posted (Estimate): December 29, 2014

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 25, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: survival; esophageal cancer; aspirin
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: NNSFC 81302455

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No