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Low-dose Aspirin Therapy for Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT02326779
Recruitment Status : Unknown
Verified January 2016 by Yihua, Wu, Zhejiang University.
Recruitment status was:  Not yet recruiting
First Posted : December 29, 2014
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Yihua, Wu, Zhejiang University

Tracking Information
First Submitted Date  ICMJE December 22, 2014
First Posted Date  ICMJE December 29, 2014
Last Update Posted Date January 5, 2016
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2014)
  • Disease-free survival [ Time Frame: 5 years ]
  • Overall survival [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02326779 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2014)
Adverse events [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-dose Aspirin Therapy for Esophageal Cancer
Official Title  ICMJE Low-dose Aspirin Therapy for Stage II-III Esophageal Cancer- A Multi-Center, Open Label, Randomized Controlled Phase III Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Cancer
Intervention  ICMJE Drug: Acetylsalicylic acid
Acetylsalicylic acid (Aspirin) 100 mg OD for 3 years
Other Name: Aspirin
Study Arms  ICMJE
  • Experimental: Experimental Arm
    Experimental Arm: acetylsalicylic acid (Aspirin) 100 mg OD for 3 years
    Intervention: Drug: Acetylsalicylic acid
  • No Intervention: Comparator Arm
    Non-aspirin use arm as comparator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 26, 2014)
600
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02326779
Other Study ID Numbers  ICMJE NNSFC 81302455
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yihua, Wu, Zhejiang University
Study Sponsor  ICMJE Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zhejiang University
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP