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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

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: Acetylsalicylic acid Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low-dose Aspirin Therapy for Stage II-III Esophageal Cancer- A Multi-Center, Open Label, Randomized Controlled Phase III Trial
Study Start Date : March 2016
Estimated Primary Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Experimental Arm
Experimental Arm: acetylsalicylic acid (Aspirin) 100 mg OD for 3 years
Drug: Acetylsalicylic acid
Acetylsalicylic acid (Aspirin) 100 mg OD for 3 years
Other Name: Aspirin

No Intervention: Comparator Arm
Non-aspirin use arm as comparator



Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 5 years ]
  2. Overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Yihua, Wu, Instructor, Zhejiang University
ClinicalTrials.gov Identifier: NCT02326779     History of Changes
Other Study ID Numbers: NNSFC 81302455
First Posted: December 29, 2014    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016
Keywords provided by Yihua, Wu, Zhejiang University:
esophageal cancer
aspirin
survival
Additional relevant MeSH terms:
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Aspirin
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics