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

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

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03734614

Sponsor: RenJi Hospital

Phase:

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.