Esophageal CancerPhase 3NCT02326779
Low-dose Aspirin Therapy for Esophageal Cancer
A Phase 3 study testing Acetylsalicylic acid in people with Esophageal Cancer, run by Zhejiang University.
Trial summary
The aim of this study is to evaluate the survival benefit of low-dose aspirin use for stage II-III esophageal cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Acetylsalicylic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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)
Who cannot join
- 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.
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- 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.
About this study
Official title: 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.
Read the 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
- Being tested
- Acetylsalicylic acid
- Keywords
- esophageal cancer, aspirin, survival
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acidDrug
Also called Aspirin
Acetylsalicylic acid (Aspirin) 100 mg OD for 3 years
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Experimental Arm: acetylsalicylic acid (Aspirin) 100 mg OD for 3 years Receives: Drug: Acetylsalicylic acid |
| Comparator Arm | No intervention | Non-aspirin use arm as comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: 5 years
Overall survival
Measured: 5 years
Secondary outcomes (1)
Adverse events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startMar 2016
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: The study could not be performed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yihua, Wu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326779
- Sponsor's protocol ID
- NNSFC 81302455
- Status last verified
- Apr 2021
- First submitted
- 22 Dec 2014
- Last updated
- 27 Apr 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Aspirin Therapy for Stage II-III Esophageal Cancer- A Multi-Center, Open Label, Randomized Controlled Phase III Trial
- ClinicalTrials.gov ID
- NCT02326779
- Acronym / sponsor ID
- NNSFC 81302455
- Conditions
- Esophageal Cancer
- Keywords
- esophageal cancer, aspirin, survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study could not be performed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Acetylsalicylic acidExperimental Arm: acetylsalicylic acid (Aspirin) 100 mg OD for 3 years |
| Comparator Arm | No intervention | –Non-aspirin use arm as comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic acidAlso: AspirinAcetylsalicylic acid (Aspirin) 100 mg OD for 3 years | Drug | Experimental Arm |
Primary outcome
Disease-free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
1 secondary outcome
Adverse events
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylsalicylic acid in people with Esophageal Cancer, run by Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.