Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma Clinical Trial
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
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.
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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