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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003040
Receipt No. R000003325
Scientific Title Randomized comparison of Sequential therapies with Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma
Date of disclosure of the study information 2010/01/15
Last modified on 2014/07/15

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Basic information
Public title Randomized comparison of Sequential therapies with Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma
Acronym CROSS-J-RCC
Scientific Title Randomized comparison of Sequential therapies with Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma
Scientific Title:Acronym CROSS-J-RCC
Region
Japan

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

Objectives
Narrative objectives1 The clinical benefits of sunitinib and sorafenib have been demonstrated in patients with cytokine-refractory metastatic renal cell carcinoma. Sunitinib has also been shown to improve progression free survival and overall survival in a comparative study with interferon-alpha. When sunitinib is used as first-line molecular-targeted therapy, switching to sorafenib is one of the treatment options after disease progression. Reversely, when sorafenib is used as first-line molecular-targeted therapy, sunitinib is used as second-line therapy. The goal of cancer treatment is cure, and if cure is not possible, it is to prolong survival. In this study, sunitinib or sorafenib will be administered as first-line molecular-targeted therapy and treatment switched to the other test drug, sorafenib or sunitinib, when disease progression is detected to assess which treatment sequence produces longer progression free survival and offers a better safety profile (causing fewer adverse events). The purpose of this trial is to compare progression free survival of first line sunitinib versus sorafenib, and that of two treatment sequences, i.e. sunitinib followed by sorafenib versus sorafenib followed by sunitinib.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes PFS in first-line treatment, Total progression free survival (PFS) in first-line and second-line treatments
Key secondary outcomes PFS in second-line treatment, Antitumor effect, survival, clinical benefit (CR+PR+NC), and adverse event

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sunitinib administration, washout period, sorafenib administration
Interventions/Control_2 sorafenib administration, washout period, sunitinib administration
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Age: 20-80 years old, both inclusive
2) ECOG performance status of 0, 1, or 2
3) MSKCC risk of favorable or intermediate
4) Histologically confirmed renal cell carcinoma
5) No ischemic heart disease
6) Laboratory findings meet the following criteria:
(1) Respiratory function: %VC, 80% and FEV1.0,70%
(2) Hematology: white blood cell count4,000/mm3, platelet count100,000/mm3
(3) Clinical chemistry: GOT and GPT within the normal range of each medical institution; total bilirubin <1.5 x ULN
(4) Serum creatinin <2.0mg/dl, blood urea nitrogen (BUN) <25mg/dl
(5) Echocardiographic estimation of left ventricular ejection fraction is higher than the lower limit of reference range of each medical institution.
Key exclusion criteria 1) History of any other malignancy
2) Central nervous system metastases. However, patients who remain asymptomatic, have no new or enlarging lesion in the CNS within 6 months of enrollment in this study, and require no corticosteroids may be enrolled.
3) History of cardiac infarction, unstable angina, congestive heart failure, or symptomatic peripheral vascular disease within 12 months of enrollment
4) History of cerebrovascular disorder including transient ischemic attack (TIA)
5) Pregnancy or possible pregnancy at any time during the study
6) Ongoing grade 2 adverse event prior treatment
7) Prior treatment with any anticancer therapy including cytokine therapy such as interferon-alpha and interleukin-2
8) Prior treatment with mTOR inhibitor
9) Prior treatment with sunitinib or sorafenib
10) Treatment with an test drug in a clinical research within 4 weeks of enrollment in this study
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Tomita
Organization Yamagata University
Division name Faculty of Medicine, Department of Urology
Zip code
Address Iida-nishi 2-2-2, Yamagata
TEL 023-628-5368
Email ytomita@med.id.yamagata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiko Tomita
Organization Yamagata University
Division name Faculty of Medicine, Department of Urology
Zip code
Address Iida-nishi 2-2-2, Yamagata
TEL 023-628-5368
Homepage URL
Email ytomita@med.id.yamagata-u.ac.jp

Sponsor
Institute Yamagata University Faculty of Medicine
Institute
Department

Funding Source
Organization Yamagata University Faculty of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 CT01481870
Org. issuing International ID_1 Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 旭川医科大学附属病院(北海道)
札幌医科大学附属病院(北海道)
北海道大学病院(北海道)
函館五稜郭病院(北海道)
弘前大学医学部附属病院(青森県)
秋田大学医学部附属病院(秋田県)
岩手医科大学附属病院(岩手県)
東北大学医学部附属病院(宮城県)
山形大学医学部付属病院(山形県)
獨協医科大学病院(栃木県)
埼玉医科大学総合医療センター(埼玉県)
防衛医科大学校病院(埼玉県)
東京女子医科大学病院(東京都)
日本大学医学部附属板橋病院(東京都)
慶応義塾大学病院(東京都)
北里大学病院(東京都)
東京慈恵会医科大学附属病院(東京都)
東京大学医学部附属病院(東京都)
日本医科大学付属病院(東京都)
千葉県がんセンター(千葉県)
神奈川県立がんセンター(神奈川県)
山梨大学医学部附属病院(山梨県)
新潟大学医歯学総合病院(新潟県)
新潟市民病院(新潟県)
県立がんセンター新潟病院(新潟県)
金沢大学付属病院(石川県)
岐阜大学医学部附属病院(岐阜県)
名古屋大学医学部附属病院(愛知県)
藤田衛生保険大学(愛知県)
京都大学附属病院(京都府)
天理よろず病院相談所病院(奈良県)
岡山大学病院(岡山県)
広島市民病院(広島県)
島根大学医学部付属病院(島根)
徳島大学病院(徳島県)
香川大学医学部附属病院(香川県)
四国がんセンター(愛媛県)
山口大学医学部附属病院(山口県)
大分大学医学部附属病院(大分県)
広島大学病院(広島県)
広島市民病院(広島県)
山口大学附属病院(山口県)
長崎大学附属病院(長崎県)
鹿児島大学病院(鹿児島県)
宮崎大学医学部附属病院(宮崎県)
琉球大学医学部附属病院(沖縄県)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 15 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 No longer recruiting
Date of protocol fixation
2010 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2015 Year 12 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
2010 Year 01 Month 15 Day
Last modified on
2014 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003325

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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