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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001994
Receipt No. R000002427
Scientific Title Phase II Randomized Comparative Study of Sequential Alternating Therapy with Interferon and Molecular-Targeted Drug for Advanced Renal Cell Carcinoma
Date of disclosure of the study information 2009/05/21
Last modified on 2018/11/01

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Basic information
Public title Phase II Randomized Comparative Study of Sequential Alternating Therapy with Interferon and Molecular-Targeted Drug for Advanced Renal Cell Carcinoma
Acronym Comparative Study of Sequential Therapy with Interferon and Molecular-Targeted Drug for Renal Cell Carcinoma
Scientific Title Phase II Randomized Comparative Study of Sequential Alternating Therapy with Interferon and Molecular-Targeted Drug for Advanced Renal Cell Carcinoma
Scientific Title:Acronym Comparative Study of Sequential Therapy with Interferon and Molecular-Targeted Drug for Renal Cell Carcinoma
Region
Japan

Condition
Condition Advanced Renal Cell Carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety between two sequential therapies, sunitinib followed by sorafenib versus interferon followed by sorafenib, in advanced renal cell carcinoma patients without prior systemic treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Sumiferon 6 million units will be subcutaneously administered three times a week, and treatment will be continued. Judgment for treatment efficacy will be made at least after 12-week treatment. At the time when PD is shown by judgment for treatment efficacy, subjects will be transferred to the secondary treatment. As the secondary treatment, Nexavar 400 mg will be orally administered twice daily every day until PD is shown.
Interventions/Control_2 SUTENT 50 mg will be orally administered once daily for 4 weeks and then treatment will be withdrawn for 2 weeks. A total of 6 weeks is 1 course, and subjects will be transferred to the secondary treatment at the time when PD is shown. As the secondary treatment, Nexavar 400 mg will be orally administered twice daily every day until PD is shown.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients histopathologically diagnosed as renal cell carcinoma with the presence of clear cell carcinoma
2. Patients with a metastatic focus limited to the lung and/or mediastinal lymph node
3. Patients with the MSKCC risk of favorable or intermediate
4. Patients with a measurable lesion in accordance with RECIST
5. Patients with a history of nephrectomy
6. Patients for whom all of acute toxicities caused by medications, radiotherapy, or surgical procedure in the past have disappeared down to Grade 1 or less of CTCAE ver. 3.0
7. Patients aged at least 20 years
8. Patients whose performance status (ECOG classification) is 0 to 1
9. Patients for whom survival for more than 3 months can be expected
10. Patients for whom functions of organs are maintained
11. Women after menopause or who agree to contraception or is surgically sterile. For men, those who agree to contraception or had an sterilization procedure
12. Patients from whom written consent is obtained
Key exclusion criteria 1.Patients who have had systemic treatment for renal cancer
2.Patients for whom the period after a surgery or the end of radiotherapy is less than 4 weeks at the start of protocol treatment
3.Patients suffering double carcinoma within 5 years. However, the following patients who received appropriate treatment are acceptable as the subjects.
a. Basal cell carcinoma of the skin or squamous cell cancer
b. Cervical cancer, stomach cancer, or colon cancer (in situ)
4.Patients diagnosed as brain metastasis, spinal cord compression, or meningitis carcinomatosa
5.Patients showing either of the following within 12 months before the start of protocol treatment:
Myocardial infarction, severe or unstable angina pectoris, coronary artery or peripheral bypass graft, symptomatic congestive heart failure, cerebrovascular attack or transient ischemic attack, or pulmonary embolism
6.Patients with arrhythmia or atrial fibrillation (any grade) by CTCAE Ver. 3.0, or QTc interval prolongation at >450 msec in men and >470 msec in women
7.Patients with uncontrollable hypertension (>150/100 mmHg in spite of the most proper medication)
8.Patients administered warfarin continuously (oral administration of a low dose of warfarin up to 2 mg/day is acceptable)
9.Patients for whom human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related diseases or hepatitis B or C virus are confirmed
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotsugu Uemura
Organization Kinki University School of Medicine
Division name Department of Urology
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Nozawa
Organization Osaka Urological Oncology Research Group
Division name Executive Office
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka, Japan
TEL
Homepage URL
Email

Sponsor
Institute Osaka Urological Oncology Research Group
Institute
Department

Funding Source
Organization Osaka Kidney Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2009 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2013 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 05 Month 21 Day
Last modified on
2018 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002427

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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