NCT03734614

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 260 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Low dose of aspirin	Low dose of aspirin, 100 mg daily for longer than one year

Timeline

• Start date: 2018-10-08
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2018-11-08
• Last updated: 2018-11-08

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study