UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Randomized Comparative Study of Sequential Alternating Therapy with Interferon and Molecular-Targeted Drug for Advanced Renal Cell Carcinoma
Title of the study (Brief title)	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Interventions/Control_2	SUTENT 50 mg will be orally administered once daily for 4 weeks and then treatment will be withdrawn for 2 weeks.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	Hirotsugu Uemura
Organization	Kinki University School of Medicine
Division name	Department of Urology
Address	377-2 Ohno-higashi, Osaka-Sayama, Osaka, Japan
TEL
Email

Public contact
Name of contact person	Masahiro Nozawa
Organization	Osaka Urological Oncology Research Group
Division name	Executive Office
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 01 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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