UMIN-CTR Clinical Trial

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

renal cell cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Yamagata University Faculty of Medicine

Institute

Department

Personal name

Organization

Yamagata University Faculty of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

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）

Date of disclosure of the study information

2010

Year

01

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2010

Year

01

Month

15

Day

Last modified on

2014

Year

07

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003325