Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell CarcinomaNCT03734614
Preventive Effects of Aspirin as Adjuvant Therapy in Patients With Locally Advanced Renal Cell Carcinoma
An observational study of Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma, run by RenJi Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma
- What is being tested?
- Low dose of aspirin
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2018to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with locally advanced renal cell carcinoma undergoing radical nephrectomy
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200123
Jiwei Huang, M.D, huangjiwei@renji.com
About this study
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
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.
- Conditions
- Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma
- Being tested
- Low dose of aspirin
- Keywords
- asprin, locally advanced, renal cell carcinoma, adjuvant therapy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose of aspirinDrug
Low dose of aspirin, 100 mg daily for longer than one year
| Study group | Role | What they receive |
|---|---|---|
| Patients with adjuvant aspirin | After surgery, patients would use low-dose aspirin (100mg) longer than 1 year Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival
Disease-free Survival
Measured: 36 mouths
Secondary outcomes (3)
Overall survival
Overall survival
Measured: 36 months
Cancer specific survival
Cancer specific survival
Measured: 36 months
adverse event rate
Rate of patients with each of the adverse event per grade
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start8 Oct 2018
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiran Huang, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734614
- Sponsor's protocol ID
- RCC ASA PREVENT1
- Status last verified
- Nov 2018
- First submitted
- 28 Oct 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03734614
- Acronym / sponsor ID
- RCC ASA PREVENT1
- Conditions
- Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma
- Keywords
- asprin, locally advanced, renal cell carcinoma, adjuvant therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with adjuvant aspirin | – | Drug: Low dose of aspirinAfter surgery, patients would use low-dose aspirin (100mg) longer than 1 year |
| Patients without adjuvant aspirin | – | –After surgery, patients would not use low-dose aspirin or use asprin shorter than 1 year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with locally advanced renal cell carcinoma undergoing radical nephrectomy
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose of aspirinLow dose of aspirin, 100 mg daily for longer than one year | Drug | Patients with adjuvant aspirin |
Primary outcome
Disease-free Survival
Time frame: 36 mouths
Disease-free Survival
3 secondary outcomes
Overall survival
Time frame: 36 months
Cancer specific survival
Time frame: 36 months
adverse event rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jiwei huang, M.D. (8613651682825, huangjiwei@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival (time frame: 36 mouths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.