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
|Condition or disease||Intervention/treatment|
|Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma||Drug: Low dose of aspirin|
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.
|Study Type :||Observational|
|Estimated Enrollment :||260 participants|
|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|
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
- Disease-free Survival [ Time Frame: 36 mouths ]Disease-free Survival
- Overall survival [ Time Frame: 36 months ]Overall survival
- Cancer specific survival [ Time Frame: 36 months ]Cancer specific survival
- adverse event rate [ Time Frame: 12 months ]Rate of patients with each of the adverse event per grade
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734614
|Contact: jiwei huang, M.D.||email@example.com|
|Renji Hospital, School of Medicine, Shanghai Jiao Tong University||Recruiting|
|Shanghai, Shanghai, China, 200123|
|Contact: Jiwei Huang, M.D firstname.lastname@example.org|