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Low-dose Aspirin Therapy for Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Acetylsalicylic acid

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal cancer, aspirin, survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Arm

Comparator Arm

Arm Description

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

Non-aspirin use arm as comparator

Outcomes

Primary Outcome Measures

Disease-free survival

Overall survival

Secondary Outcome Measures

Adverse events

Full Information

NCT ID

NCT02326779

First Posted

December 22, 2014

Last Updated

April 25, 2021

Sponsor

Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT02326779

Brief Title

Low-dose Aspirin Therapy for Esophageal Cancer

Official Title

Low-dose Aspirin Therapy for Stage II-III Esophageal Cancer- A Multi-Center, Open Label, Randomized Controlled Phase III Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Withdrawn

Why Stopped

The study could not be performed.

Study Start Date

March 2016 (undefined)

Primary Completion Date

October 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

Keywords

esophageal cancer, aspirin, survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Arm

Arm Type

Experimental

Arm Description

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

Arm Title

Comparator Arm

Arm Type

No Intervention

Arm Description

Non-aspirin use arm as comparator

Intervention Type

Drug

Intervention Name(s)

Acetylsalicylic acid

Other Intervention Name(s)

Aspirin

Intervention Description

Acetylsalicylic acid (Aspirin) 100 mg OD for 3 years

Primary Outcome Measure Information:

Title

Disease-free survival

Time Frame

5 years

Title

Overall survival

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Adverse events

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Learn more about this trial

Low-dose Aspirin Therapy for Esophageal Cancer

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