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

Sponsor

RenJi Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03734614

Collaborator

(none)

260

Enrollment

Location

71.8

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Oct 8, 2018

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Disease-free Survival [36 mouths]
Disease-free Survival

Secondary Outcome Measures

Overall survival [36 months]
Overall survival
Cancer specific survival [36 months]
Cancer specific survival
adverse event rate [12 months]
Rate of patients with each of the adverse event per grade

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.