A Multi-Center, Non-Controlled Clinical Study of Sorafenib Adjuvant Therapy in Advanced Renal-Cell Carcinoma (AGuo)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Chinese Academy of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
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
Information provided by:
Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01041482
First received: December 30, 2009
Last updated: January 5, 2010
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Renal Cell Carcinoma
Drug: sorafenib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Non-Controlled Clinical Study of Sorafenib Adjuvant Therapy in Locally Advanced Renal-Cell Carcinoma After Radical Nephrectomy

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • disease free survival [ Time Frame: November 2008-November 2013 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: November 2008-November 2013 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: November 2008
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sorafenib
To study the efficacy of Sorafenib as an adjuvant therapy for reducing recurrence rate in locally advanced renal-cell carcinoma (RCC) after radical nephrectomy.
Drug: sorafenib
sorafenib 400mg twice daily
Other Name: sorafenib

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041482

Contacts
Contact: China Academy of Medical Sciences Jianhui Ma China Academy of Medical Sciences, Doctor 01086108778
Contact: China Academy of Medical Sciences Jianhui Ma China Academy of Medical Sciences 01086108778

Locations
China, Beijing
Jianhui Ma Recruiting
Beijing, Beijing, China, 100730
Contact: Jianhui Ma Jianhui Ma Jianhui Ma, Doctor    01086108878      
Sponsors and Collaborators
Chinese Academy of Medical Sciences
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
  More Information

No publications provided

Responsible Party: Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01041482     History of Changes
Other Study ID Numbers: Bay 43-9006
Study First Received: December 30, 2009
Last Updated: January 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
sorafenib
renal cell carcinoma
disease free survival
Hand food skin reaction

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014