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Status unknownNCT03734614Updated Nov 8, 2018

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

An observational study in Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-08.

Sponsored by RenJi Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
260
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • asprin
  • locally advanced
  • renal cell carcinoma
  • adjuvant therapy
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 260 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with locally advanced renal cell carcinoma undergoing radical nephrectomy

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
260 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with adjuvant aspirin

    After surgery, patients would use low-dose aspirin (100mg) longer than 1 year

    Drug: Low dose of aspirin

  • Patients without adjuvant aspirin

    After surgery, patients would not use low-dose aspirin or use asprin shorter than 1 year

Interventions

  • DrugLow dose of aspirin

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

06

What researchers measure

Primary outcomes

  1. Disease-free Survival

    Disease-free Survival

    Time frame: 36 mouths

Secondary outcomes

  1. Overall survival

    Overall survival

    Time frame: 36 months

  2. Cancer specific survival

    Cancer specific survival

    Time frame: 36 months

  3. adverse event rate

    Rate of patients with each of the adverse event per grade

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
    Shanghai, Shanghai 200123, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03734614
Lead sponsor
RenJi Hospital
Responsible party
Yiran Huang (Professor of Urology, RenJi Hospital) — Principal investigator
First posted
Nov 8, 2018
Start date
Oct 8, 2018
Primary completion
Oct 2024 (estimated)
Completion
Oct 2024 (estimated)
Last update
Nov 8, 2018

Study contacts

jiwei huang, M.D.
Contact
huangjiwei@renji.com
8613651682825

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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