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

• ClinicalTrials.gov Identifier: NCT03734614
• Recruitment Status: Recruiting
• First Posted: November 8, 2018
• Last Update Posted: November 8, 2018
• Sponsor: RenJi Hospital
• Information provided by (Responsible Party): Yiran Huang, RenJi Hospital

Tracking Information

• First Submitted Date: October 28, 2018
• First Posted Date: November 8, 2018
• Last Update Posted Date: November 8, 2018
• Actual Study Start Date: October 8, 2018
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 7, 2018)

Disease-free Survival [ Time Frame: 36 mouths ]

Disease-free Survival

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 7, 2018)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: patients with locally advanced renal cell carcinoma undergoing radical nephrectomy
• Condition: Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma

Intervention

Drug: Low dose of aspirin

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

Study Groups/Cohorts

• Patients with adjuvant aspirin
  After surgery, patients would use low-dose aspirin (100mg) longer than 1 year
  Intervention: 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 7, 2018): 260
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2024
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03734614
• Other Study ID Numbers: RCC ASA PREVENT1
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Yiran Huang, RenJi Hospital
• Study Sponsor: RenJi Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: RenJi Hospital
• Verification Date: November 2018