Low-dose Aspirin Therapy for Esophageal Cancer

NCT02326779 | Withdrawn Phase 3

• 1 other identifier: NNSFC 81302455
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Cancer

Keywords

esophageal cancer; aspirin; survival

Outcome Measures

Primary Outcomes (2)

• Disease-free survival

  5 years

• Overall survival

  5 years

Secondary Outcomes (1)

• Adverse events

  5 years

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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

Drug: Acetylsalicylic acid

Comparator Arm

NO INTERVENTION

Non-aspirin use arm as comparator

Interventions

Acetylsalicylic acid DRUG

Acetylsalicylic acid (Aspirin) 100 mg OD for 3 years

Also known as: Aspirin

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 29, 2014
• Study Start: March 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 27, 2021

Record last verified: 2021-04