UMIN-CTR Clinical Trial

Basic information
Public title	Percutaneous cryoablation of renal cell carcinoma smaller than 4 cm: Phase II clinical trial
Acronym	SCIRO-1302 study
Scientific Title	Percutaneous cryoablation of renal cell carcinoma smaller than 4 cm: Phase II clinical trial
Scientific Title:Acronym	SCIRO-1302 study
Region	Japan

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

Objectives
Narrative objectives1	The evaluation of efficacy of percutaneous cryoablation of renal cell carcinoma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Cause specific survival (CSS)
Key secondary outcomes	Frequency of adverse events Overall survival(OS) Local progression rate Recurrence free survival (RFS) Imaging findings

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
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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) Tumor is histologically or clinically diagnosed as RCC. 2) The tumor is measurable and its maximum diameter of RCC is <= 4.0 cm in diameter. Two or more tumors were permitted. 3) Patient is not indicated for curative resection or refused the surgery 4) Patient's age is >= 20 years old. 5) Patient's performance status (ECOG) is 0 or 1. 6) Laboratory requirements, tested within 14 days prior to the first TRAE in this study, as defined below a)White blood cell (WBC) count >= 2500 per mm3 b)Platelet count >= 50,000 per mm3 c)Hemoglobin >= 7.5 g/dL d)Total bilirubin <= 2.0 mg/dl e)Prothrombin time-international normalized ratio (PT-INR) <= 1.5 7)Patient is able to provide written informed consent.
Key exclusion criteria	1) Patients with extra-renal tumor spread 2) Patients with vascular invasion like venous tumor thrombus 3) There is a vital organ or major vessel along expected puncture line. 4) Patients have allergy for alcohol or contrast medium (iodine). 5) Patients have severe comorbidities as follows: a) Congestive heart failure failure (&#8805;NYHA III) b) Active or uncontrolled clinically serious infection (excluding chronic hepatitis) 6) Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, excluding carcinoma in situ, cancers corresponding to intraepithelial or intramucosal neoplasia, any cancer curatively treated or, breast cancer/prostatic cancer in carcinostatic state. 7) Patients have a fever more than 38 C degree. 8) Patients is difficult to receive imaging evaluation like computed tomography (CT) or magnetic resonance imaging (MRI) 9) Female patients who are pregnant. 10) Any patients who is considered unsuitable for being enrolled in this clinical trial by an attending physician.
Target sample size	33

Research contact person
Name of lead principal investigator	1st name Middle name Last name Susumu Kanazawa
Organization	Okayama University Hospital
Division name	Department of Radiology
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	+81-86-235-7315
Email	susumu@cc.okayama-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hideo Gobara
Organization	Okayama University Hospital
Division name	Department of Radiology
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	+81-86-235-7315
Homepage URL
Email	gobara@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	None
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	岡山大学病院（岡山県）

Other administrative information
Date of disclosure of the study information	2013 Year 10 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	No longer recruiting
Date of protocol fixation	2013 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The relation between efficacy of cryoablation for renal cell carcinoma and cause specific survival survival Single center prospective cohort study

Management information
Registered date	2013 Year 10 Month 01 Day
Last modified on	2017 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013906

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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