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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03734614
• Other study ID #: RCC ASA PREVENT1
• Status: Recruiting
• Start date: October 8, 2018
• Est. completion date: October 2024

Study information

• Verified date: November 2018
• Source: RenJi Hospital
• Contact: jiwei huang, M.D.
• Phone: 8613651682825
• Email: huangjiwei[@]renji.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Low dose of aspirin
Low dose of aspirin, 100 mg daily for longer than one year

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free Survival	Disease-free Survival	36 mouths
Secondary	Overall survival	Overall survival	36 months
Secondary	Cancer specific survival	Cancer specific survival	36 months
Secondary	adverse event rate	Rate of patients with each of the adverse event per grade	12 months