Low-dose Aspirin Therapy for Esophageal Cancer | NCT02326779

Studies
Low-dose Aspirin Therapy for Esophageal Cancer

NCT02326779

Sponsor

Zhejiang University

Status

Withdrawn

Last Update Posted

Apr 27, 2021Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Esophageal Cancer

Interventions

Acetylsalicylic acid

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study could not be performed.

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Oct 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Dec 22, 2014

First Submission Date that Met QC Criteria

Dec 26, 2014

First Posted Date

Dec 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2021

Last Update Posted Date

Apr 27, 2021Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Acetylsalicylic acid	Drug	Acetylsalicylic acid (Aspirin) 100 mg OD for 3 years	Experimental Arm

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

Measure	Description	Time Frame
Adverse events		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives