Clinical trial NCT03734614: Preventive Effects of Aspirin as Adjuvant Therapy in Patients With Locally Advanced Renal Cell Carcinoma
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma
Keywords: asprin
locally advanced
renal cell carcinoma
adjuvant therapy
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with locally advanced renal cell carcinoma undergoing radical nephrectomy

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free Survival
timeFrame: 36 mouths
Secondary outcomes:
measure: Overall survival
timeFrame: 36 months
measure: Cancer specific survival
timeFrame: 36 months
measure: adverse event rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
References: