UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Parallel Group Phase II Clinical Study of Sorafenib/Interferon Combination Therapy and Sunitinib Monotherapy for Advanced Renal Cell Carcinoma
Title of the study (Brief title)	Comparative Study of Sorafenib/IFN Combination Therapy and Sunitinib Monotherapy for Advanced RCC
Region	Japan

Condition
Condition	Advanced renal cell carcinoma
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The efficacy and safety of sorafenib/IFN combination therapy and sunitinib monotherapy for progressive renal cell carcinoma are comparatively studied in patients without history of systemic therapy for progressive renal cell carcinoma.
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
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	Four-week subcutaneous administration of Sumiferon 6 million units three times a week is followed by oral administration of sorafenib 400 mg bid. The combination therapy with Sumiferon and sorafenib is continued until the disease status is assessed as PD.
Interventions/Control_2	Four-week oral administration of sunitinib 50 mg qd is followed by 2-week drug withdrawal: this 6-week course is repeated until the disease status is PD.
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 diagnosed as having renal cell carcinoma with histopathological clear cell carcinoma components 2.Patients with extrapulmonary metastasis or poor-risk patients in MSKCC risk category 3.Patients with measurable lesions according to the RECIST 4.Patients in whom drug therapy, radiotherapy, or surgical therapy lowered the acute toxicity to Grade 1 or below according to the CTCAE ver. 3.0 5.Patients aged 20 years or older 6.Patients in whom performance status in ECOG (Eastern Cooperative Oncology Group) classification is 0 to 1 7.Patients who are expected to survive for at least 3 months 8.Patients in whom the function of primary organs are retained 9.Female patients who are postmenopausal have consented to contraception or has been surgically sterilized. Male patients who have consented to contraception or received sterilization 10.Patients from whom the informed consent is obtained in writing
Key exclusion criteria	1.Patients who have received systemic therapy for renal carcinoma 2.Patients who completed the surgery or radiotherapy for renal carcinoma less than 4 weeks before initiation of the present study 3.Patients suffering from multiple cancers within last 5 years, excepting those who received appropriate treatment for the following a. Basal cell carcinoma or squamous cell carcinoma of skin b. Uterine cervix carcinoma, gastric cancer or large intestine carcinoma (in situ) 4. Patients who are diagnosed as having cerebral metastasis, meningeal metastasis, spinal cord compression, or meningitis carcinomatosa 5. Patients who are found to have either of the following diseases within 12 months before initiation of the present study Myocardial infarction, severe or unstable angina, coronary or peripheral arterial bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism 6. Patients with arrhythmia (Grade 2 or severer according to the CTCAE ver. 3.0) or atrial fibrillation (regardless of Gragde), or male patients with QTc interval prolonged over 450 msec or female patients with QTc interval prolonged over 470 msec
Target sample size	200

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	2012 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=R000002432