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

Primary Purpose

Renal Cell Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
sorafenib
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring sorafenib, renal cell carcinoma, disease free survival, Hand food skin reaction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jianhui MaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sorafenib

Arm Description

To study the efficacy of Sorafenib as an adjuvant therapy for reducing recurrence rate in locally advanced renal-cell carcinoma (RCC) after radical nephrectomy.

Outcomes

Primary Outcome Measures

disease free survival

Secondary Outcome Measures

overall survival

Full Information

First Posted
December 30, 2009
Last Updated
January 5, 2010
Sponsor
Chinese Academy of Medical Sciences
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
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1. Study Identification

Unique Protocol Identification Number
NCT01041482
Brief Title
A Multi-Center, Non-Controlled Clinical Study of Sorafenib Adjuvant Therapy in Advanced Renal-Cell Carcinoma
Acronym
AGuo
Official Title
A Multi-Center, Non-Controlled Clinical Study of Sorafenib Adjuvant Therapy in Locally Advanced Renal-Cell Carcinoma After Radical Nephrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
November 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese Academy of Medical Sciences
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
sorafenib, renal cell carcinoma, disease free survival, Hand food skin reaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sorafenib
Arm Type
Experimental
Arm Description
To study the efficacy of Sorafenib as an adjuvant therapy for reducing recurrence rate in locally advanced renal-cell carcinoma (RCC) after radical nephrectomy.
Intervention Type
Drug
Intervention Name(s)
sorafenib
Intervention Description
sorafenib 400mg twice daily
Primary Outcome Measure Information:
Title
disease free survival
Time Frame
November 2008-November 2013
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
November 2008-November 2013

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
China Academy of Medical Sciences Jianhui Ma China Academy of Medical Sciences, Doctor
Phone
01086108778
First Name & Middle Initial & Last Name or Official Title & Degree
China Academy of Medical Sciences Jianhui Ma China Academy of Medical Sciences
Phone
01086108778
Facility Information:
Facility Name
Jianhui Ma
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhui Ma Jianhui Ma Jianhui Ma, Doctor
Phone
01086108878

12. IPD Sharing Statement

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

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