Renal Cell CarcinomaPhase 2AGuoNCT01041482
A Multi-Center, Non-Controlled Clinical Study of Sorafenib Adjuvant Therapy in Advanced Renal-Cell Carcinoma
A Phase 2 study testing sorafenib in people with Renal Cell Carcinoma, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
A one-arm,open,multi-center study, to evaluate sorafenib (400mg twice daily ) as a adjuvant to prevent recurrence of RCC(renal cell carcinoma) patients after radical nephrectomy with a high-risk of recurring. To observe disease-free survival and the survival rate in 3 years,5 years. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- sorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Nov 2008to Nov 2013
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperative Criteria
- Renal local advanced renal cell carcinoma and be suitable to radical nephrectomy.
- Tumor >=7cm, the lymph nodes in metastasis can be resectable, the renal vein or inferior caval vein with metastatic thrombus can be resectable also, clinical staging>=T2anyNMo.
- Resectable tumor with multiple-lesion in ipsolateral kidney Enrolment Criteria
- No distant metastasis.
- Not undergoing any adjuvant or systematic anti-tumor therapy, such as chemotherapy, biotherapy or radiotherapy.
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- After the nephrectomy 4-12 weeks and should be recovery in the postoperative complications.
- ECOG scores 0-1.
- Referring to the Scoring Algorithm to Predict Metastasis after Radical Nephrectomy in Patients with clear cell renal cell carcinoma, all the patients score higher than 6. Metastatic lymph node with clinical diagnosis have been resected, all the resected specimen edge be negative in pathological detection.
- The pathological diagnosis of renal cell carcinoma:
- No remnant tumor with postoperative imaging screening with CT or MRI.
- The liver and renal function, hemocytogenesis function meet the below criteria within the 4 weeks before the enrollment.
- Granulocytes count >1500/mm3
- Blood platelet >100000/mm3
- Creatinine<2 times of the upper of the reference value
- Total bilirubin<1.5 times of the upper of the reference value
- Alanine aminotransferase/aspartate aminotransferase<2.5 times of the upper of the reference value
- The informed consent has been endorsed.
Who cannot join
- Other coincident carcinoma, but not including carcinoma in situ of cervix and basal cell epithelioma after radical therapy and bladder carcinoma superficially(Ta,Tis,T1) or carcinoma having been cured 3 years ago.
- Cardiac dysrhythmia need agent intervention(not including β-receptor inhibitive or digoxin treatment), coronary heart disease, myocardial infarction occurred in the later 6 months, heart failure assessment higher than NYHA II
- Seriously active infection with bacteria or fungus
- HIV infection or HBV/HCV infection with IFN-a intervention.
- Dysfunction in blood coagulation.
- Epilepsia with drug treatment.
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- Those cannot take tablets orally.
- Allogeneic organ transplantation.
- Drug abuse or concomitant conditions such as psychologically or socially factors which may intervene the assessment.
- Hypersensitiveness to the studying adjuvant or the trial-relevant drugs.
- Pregnancy or lactation, pregnancy test must be negative within the 14 days before the trial beginning, either females or males must be contraceptive during the trial.
- The following concomitant therapeutics must be excluded:
- Anti-tumor agents, immunological or hormonal therapy
- Radiotherapy
- Biological therapeutics such as G-CSF or GM-CSF
- Autologous bone marrow transplantation or stem cell treatment
- The other trial medicine therapeutics
- Bevacizumab treatment or other agents effected in VEGF or VEGF-receptor, such as inhibitive in Raf or MEK
Trial locations and contacts
1 site in 1 country.
China Academy of Medical Sciences Jianhui Ma China Academy of Medical Sciences, Doctor contact
China Academy of Medical Sciences Jianhui Ma China Academy of Medical Sciences contact
China1 site, 1 recruiting
- Recruiting
Jianhui Ma
Beijing, Beijing Municipality, 100730
Jianhui Ma Jianhui Ma Jianhui Ma, Doctor, 01086108878
About this study
Official title: A Multi-Center, Non-Controlled Clinical Study of Sorafenib Adjuvant Therapy in Locally Advanced Renal-Cell Carcinoma After Radical Nephrectomy
A one-arm,open,multi-center study, to evaluate sorafenib (400mg twice daily ) as a adjuvant to prevent recurrence of RCC(renal cell carcinoma) patients after radical nephrectomy with a high-risk of recurring. To observe disease-free survival and the survival rate in 3 years,5 years.
The purpose of this study is:
Read more
- To study the efficacy of Sorafenib as an adjuvant therapy for reducing recurrence rate in locally advanced renal-cell carcinoma (RCC) after radical nephrectomy.
- To observe the incidence of hand-foot skin reaction (HFSR) after the Urea (10% or 5%) based cream intervention treatment.
The primary end point is the disease-free survival(DFS).The secondary end point is overall survival(OS),the drug safety and tolerance, the occurrence of hand foot skin reaction(HFSR) at the week of 3,6,12,the skin toxicity(not include HFSR) higher than CTCAE(Common Terminology Criteria for Adverse Events) Grade 2 at the 12th week, the incidence of HFSR after the Urea (10% or 5%) based cream intervention treatment.
Read the detailed description
A one-arm, open, multi-center study, to evaluate sorafenib (400mg twice daily) as a adjuvant to prevent recurrence of RCC(renal cell carcinoma) patients after radical nephrectomy with a high-risk of recurring. To observe disease-free survival and the survival rate in 3 years, and 5 years. To observe the incidence of hand-foot skin reaction (HFSR) after the Urea (10% or 5%) based cream intervention treatment. 140 subjects are prospected to enter the trial.
The sorafenib adjuvant therapy is unremitting with a time of 12 months. For a convenient record, every 6 weeks is regarded as a single observational cycle. The end-point are recurrence, not being tolerant to the toxicity, need to stop the intervening study or withdrawing the informed consent. It is necessary to evaluate the efficacy and safety every 6 weeks. At the screening stage and every 12 weeks imaging review are performed such as abdominal and chest CT or MRI, the imaging methods of a single subject should be in uniformity during the trial.
The post-treatment evaluation are performed 30 days after the last usage of the adjuvant in order to collect all the adverse events (AE) and the survival rates of all the subjects. The agent-relevant AE (known or unknown) should be reported to the drug safety institution, the patients should be visited until the events solved, except the events can not be solved for the subjects' underlying diseases.
- Conditions
- Renal Cell Carcinoma
- Being tested
- sorafenib
- Keywords
- sorafenib, renal cell carcinoma, disease free survival, Hand food skin reaction
- 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.
sorafenibDrug
sorafenib 400mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| sorafenib | Experimental | To study the efficacy of Sorafenib as an adjuvant therapy for reducing recurrence rate in locally advanced renal-cell carcinoma (RCC) after radical nephrectomy. Receives: Drug: sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Measured: November 2008-November 2013
Secondary outcomes (1)
overall survival
Measured: November 2008-November 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startNov 2008
- Primary completionNov 2011 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, China Medical University, China, Peking Union Medical College Hospital, Tianjin Medical University, Shanghai Jiao Tong University School of Medicine, Changhai Hospital, Zhejiang University, Fudan University, Jiangsu Province Centers for Disease Control and Prevention, Central South University, Sichuan University, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041482
- Sponsor's protocol ID
- Bay 43-9006
- Acronym
- AGuo
- Status last verified
- Aug 2008
- First submitted
- 30 Dec 2009
- Last updated
- 6 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Non-Controlled Clinical Study of Sorafenib Adjuvant Therapy in Locally Advanced Renal-Cell Carcinoma After Radical Nephrectomy
- ClinicalTrials.gov ID
- NCT01041482
- Acronym / sponsor ID
- AGuo / Bay 43-9006
- Conditions
- Renal Cell Carcinoma
- Keywords
- sorafenib, renal cell carcinoma, disease free survival, Hand food skin reaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, China Medical University, China, Peking Union Medical College Hospital, Tianjin Medical University, Shanghai Jiao Tong University School of Medicine, Changhai Hospital, Zhejiang University, Fudan University, Jiangsu Province Centers for Disease Control and Prevention, Central South University, Sichuan University, Huazhong University of Science and Technology
- Study start
- Nov 2008
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 31 Dec 2009 (estimated)
- 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.
A one-arm,open,multi-center study, to evaluate sorafenib (400mg twice daily ) as a adjuvant to prevent recurrence of RCC(renal cell carcinoma) patients after radical nephrectomy with a high-risk of recurring. To observe disease-free survival and the survival rate in 3 years,5 years.
The purpose of this study is:
- To study the efficacy of Sorafenib as an adjuvant therapy for reducing recurrence rate in locally advanced renal-cell carcinoma (RCC) after radical nephrectomy.
- To observe the incidence of hand-foot skin reaction (HFSR) after the Urea (10% or 5%) based cream intervention treatment.
The primary end point is the disease-free survival(DFS).The secondary end point is overall survival(OS),the drug safety and tolerance, the occurrence of hand foot skin reaction(HFSR) at the week of 3,6,12,the skin toxicity(not include HFSR) higher than CTCAE(Common Terminology Criteria for Adverse Events) Grade 2 at the 12th week, the incidence of HFSR after the Urea (10% or 5%) based cream intervention treatment.
Detailed description
A one-arm, open, multi-center study, to evaluate sorafenib (400mg twice daily) as a adjuvant to prevent recurrence of RCC(renal cell carcinoma) patients after radical nephrectomy with a high-risk of recurring. To observe disease-free survival and the survival rate in 3 years, and 5 years. To observe the incidence of hand-foot skin reaction (HFSR) after the Urea (10% or 5%) based cream intervention treatment. 140 subjects are prospected to enter the trial.
The sorafenib adjuvant therapy is unremitting with a time of 12 months. For a convenient record, every 6 weeks is regarded as a single observational cycle. The end-point are recurrence, not being tolerant to the toxicity, need to stop the intervening study or withdrawing the informed consent. It is necessary to evaluate the efficacy and safety every 6 weeks. At the screening stage and every 12 weeks imaging review are performed such as abdominal and chest CT or MRI, the imaging methods of a single subject should be in uniformity during the trial.
The post-treatment evaluation are performed 30 days after the last usage of the adjuvant in order to collect all the adverse events (AE) and the survival rates of all the subjects. The agent-relevant AE (known or unknown) should be reported to the drug safety institution, the patients should be visited until the events solved, except the events can not be solved for the subjects' underlying diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sorafenib | Experimental | Drug: sorafenibTo study the efficacy of Sorafenib as an adjuvant therapy for reducing recurrence rate in locally advanced renal-cell carcinoma (RCC) after radical nephrectomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Preoperative Criteria
- Renal local advanced renal cell carcinoma and be suitable to radical nephrectomy.
- Tumor >=7cm, the lymph nodes in metastasis can be resectable, the renal vein or inferior caval vein with metastatic thrombus can be resectable also, clinical staging>=T2anyNMo.
- Resectable tumor with multiple-lesion in ipsolateral kidney Enrolment Criteria
- No distant metastasis.
Key exclusion criteria (18 listed)
- Other coincident carcinoma, but not including carcinoma in situ of cervix and basal cell epithelioma after radical therapy and bladder carcinoma superficially(Ta,Tis,T1) or carcinoma having been cured 3 years ago.
- Cardiac dysrhythmia need agent intervention(not including β-receptor inhibitive or digoxin treatment), coronary heart disease, myocardial infarction occurred in the later 6 months, heart failure assessment higher than NYHA II
- Seriously active infection with bacteria or fungus
- HIV infection or HBV/HCV infection with IFN-a intervention.
- Dysfunction in blood coagulation.
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 |
|---|---|---|
| sorafenibsorafenib 400mg twice daily | Drug | sorafenib |
Primary outcome
disease free survival
Time frame: November 2008-November 2013
1 secondary outcome
overall survival
Time frame: November 2008-November 2013
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2010.
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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.
China Academy of Medical Sciences Jianhui Ma China Academy of Medical Sciences, Doctor contact
China Academy of Medical Sciences Jianhui Ma China Academy of Medical Sciences contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sorafenib in people with Renal Cell Carcinoma, run by Chinese Academy of Medical Sciences 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 18 inclusion and 18 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 6 Jan 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 China Academy of Medical Sciences Jianhui Ma China Academy of Medical Sciences, Doctor (01086108778), 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: November 2008-November 2013). 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 6 Jan 2010.