UMIN-CTR Clinical Trial

Basic information
Public title	Surgical outcomes in patients who received presurgical treatment with pazopanib for advanced renal cell carcinoma with inferior vena cava tumor thrombus; a historical control study
Acronym	Surgical outcomes in patients who received presurgical treatment with pazopanib for advanced renal cell carcinoma with inferior vena cava tumor thrombus; a historical control study
Scientific Title	Surgical outcomes in patients who received presurgical treatment with pazopanib for advanced renal cell carcinoma with inferior vena cava tumor thrombus; a historical control study
Scientific Title:Acronym	Surgical outcomes in patients who received presurgical treatment with pazopanib for advanced renal cell carcinoma with inferior vena cava tumor thrombus; a historical control study
Region	Japan

Condition
Condition	Renal cell carcinoma
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	We evaluate improvement of surgical outcome of resection both tumor and thrombus by presurgical treatment with pazopanib in patients with advanced renal cell carcinoma (RCC) with inferior vena cava tumor thrombus.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	bleeding volume in surgery
Key secondary outcomes	-Improvement of surgical invasion: Outcome of change from surgical procedure expected before surgery to minimally invasive surgical procedure due to tumor reduction. -Operation time -Grade 3 or higher complications -Reduction in the level of tumor embolism according to the classification of Mayo clinic -Reduction rate of primary tumor and metastatic lesion.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	12 weeks oral administration of pazopanib. Surgical excision of tumor and thrombus within 7 days and 21 days from the end date of pazopanib administration
Interventions/Control_2
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.Renal cell carcinoma with tumor thrombus 2.Tumor thrombus which reach Inferior vena cava 3.Written informed consent
Key exclusion criteria	1.Patients who did not participate in this study 2.Patients who participated in other clinical trials within 4 months. 3.Performance Status> 3 4.AST,ALT> 3.0*upper limit of normal range(ULN), or total Bil> 2.0*ULN 5.Patients who receive treatment of other cancer
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomoaki Terakawa
Organization	Kobe University Graduate School of Medicine
Division name	Urology
Zip code
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN,
TEL	0783826155
Email	daatera0804@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Yasuyoshi Okamura
Organization	Kobe university Graduate School of Medicine
Division name	Urology
Zip code
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN,
TEL	0783826155
Homepage URL
Email	dfgky008@gmail.com

Sponsor
Institute	Kobe university Graduate School of Medicine Division of Urology
Institute
Department

Funding Source
Organization	Kobe university Graduate School of Medicine Division of Urology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	神戸大学医学部付属病院

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 01 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	Completed
Date of protocol fixation	2018 Year 11 Month 01 Day
Date of IRB	2019 Year 05 Month 24 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 07 Day
Last modified on	2020 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039667