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Preventive Effects of Aspirin as Adjuvant Therapy in Patients With Locally Advanced Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT03734614
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Yiran Huang, RenJi Hospital

Brief Summary:
The study evaluates the protective effect of low-dose aspirin use as adjuvant therapy on locally advanced renal cell carcinoma in users and non-users of aspirin in Renji Hospital, Shanghai, China.

Condition or disease Intervention/treatment
Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma Drug: Low dose of aspirin

Detailed Description:

Renal cell carcinoma (RCC) accounts for 2%~3% of all malignant tumors worldwide. In China, the incidence of renal cancer is increasing year by year. It is reported about one-third of patients were at late stage when diagnosed while about one-third of patients who received surgical treatment would eventually lead to recurrence or metastasis. The 5-years survival is only about 50% in patients with locally advanced RCC, which lacks of effective adjuvant treatments, although the S-TRAC study showed improved Disease-free Survival (DFS) in high-risk renal cell carcinoma after nephrectomy.

Aspirin, also called acetylsalicylic acid, belongs to non-steroidal anti-inflammatory drugs (NSAIDs). Its inhibitory effect on platelet aggregation makes it widely used in cardiovascular and cerebrovascular diseases. In addition, a number of epidemiology, basic and clinical researches confirmed that aspirin may be the most promising chemopreventive agent to date, especially against CRC. Prospective studies have also shown that aspirin can improve survival of patients with breast cancer,colorectal cancer, gastro-esophageal cancer and prostate cancer.

In the investigator's clinical practice, we'd like to investigate the preventive effects of low-dose aspirin use as an adjuvant therapy after radical nephrectomy on disease recurrence/metastasis and survival in patients with locally advanced renal cell carcinoma in Renji Hospital affiliated to Shanghai Jiao Tong University school of medicine. The study is observational and prospective, patients with locally advanced RCC will decide whether or not to take low-dose Aspirin(100mg/d) after radical nephrectomy as adjuvant therapy for 1 year. The primary end point was the duration of disease-free survival, and the secondary end points included overall survival and safety.


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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preventive Effects of Low-dose Aspirin as Adjuvant Therapy After Radical Nephrectomy on Disease Recurrence/Metastasis and Survival in Patients With Locally Advanced Renal Cell Carcinoma: an Observational Prospective Cohort Study
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Group/Cohort Intervention/treatment
Patients with adjuvant aspirin
After surgery, patients would use low-dose aspirin (100mg) longer than 1 year
Drug: Low dose of aspirin
Low dose of aspirin, 100 mg daily for longer than one year

Patients without adjuvant aspirin
After surgery, patients would not use low-dose aspirin or use asprin shorter than 1 year



Primary Outcome Measures :
  1. Disease-free Survival [ Time Frame: 36 mouths ]
    Disease-free Survival


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 36 months ]
    Overall survival

  2. Cancer specific survival [ Time Frame: 36 months ]
    Cancer specific survival

  3. adverse event rate [ Time Frame: 12 months ]
    Rate of patients with each of the adverse event per grade



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with locally advanced renal cell carcinoma undergoing radical nephrectomy
Criteria

Inclusion Criteria:

  • Patients must complete radical surgery more than 4 weeks and less than 12 weeks prior to study entry
  • Patients must have histologically or cytologically confirmed renal cell carcinoma. Using 2017 (American Joint Committee on Cancer [AJCC] 8th edition) TNM Staging, patients must be one of the following:
  • pT2aG3 or G4N0M0
  • pT2bG(any)N0M0
  • pT3G(any)N0M0
  • pT4G(any)N0M0
  • pT(any)G(any)N1M0
  • Patients must have no clinical or imaging evidence of visible residual lesions or distant metastases (M0) after nephrectomy
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Patients must be able to swallow pills

Exclusion Criteria:

  • Patients with haemorrhagic diathesis (i.e. haemophilia).
  • Patients with prior malignant tumors except for kidney cancers in the past 5 years.
  • Patients with documented or suspected metastases.
  • Patients with serious, nonhealing wound, ulcer, or bone fracture.
  • Patients with a history of stroke, coronary arterial disease, angina, or vascular disease.
  • Patients who are pregnant, lactating, or not using adequate contraception.
  • Patients who have known allergy to NSAID or Aspirin.
  • Patients receiving other antiplatelet agents (i.e. clopidogrel, ticlopidine) or anticoagulants (i.e. warfarin, low molecular weight heparins).
  • Patients receiving current long term treatment (≥1 month) with Aspirin or other NSAIDs.
  • Subject unwilling or unable to comply with study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734614


Contacts
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Contact: jiwei huang, M.D. 8613651682825 huangjiwei@renji.com

Locations
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China, Shanghai
Renji Hospital, School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200123
Contact: Jiwei Huang, M.D       huangjiwei@renji.com   
Sponsors and Collaborators
RenJi Hospital

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Responsible Party: Yiran Huang, Professor of Urology, RenJi Hospital
ClinicalTrials.gov Identifier: NCT03734614     History of Changes
Other Study ID Numbers: RCC ASA PREVENT1
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Yiran Huang, RenJi Hospital:
asprin
locally advanced
renal cell carcinoma
adjuvant therapy

Additional relevant MeSH terms:
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Aspirin
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic 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