UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001995 |
|---|---|
| Receipt number | R000002432 |
| Scientific Title | Randomized Parallel Group Phase II Clinical Study of Sorafenib/Interferon Combination Therapy and Sunitinib Monotherapy for Advanced Renal Cell Carcinoma |
| Date of disclosure of the study information | 2009/05/21 |
| Last modified on | 2018/11/01 19:20:21 |
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Basic information
Public title
Randomized Parallel Group Phase II Clinical Study of Sorafenib/Interferon Combination Therapy and Sunitinib Monotherapy for Advanced Renal Cell Carcinoma
Acronym
Comparative Study of Sorafenib/IFN Combination Therapy and Sunitinib Monotherapy for Advanced RCC
Scientific Title
Randomized Parallel Group Phase II Clinical Study of Sorafenib/Interferon Combination Therapy and Sunitinib Monotherapy for Advanced Renal Cell Carcinoma
Scientific Title:Acronym
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
| 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
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
Sponsor or person
Institute
Osaka Urological Oncology Research Group
Institute
Department
Personal name
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
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
| 2012 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002432
