UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012230
Receipt No. R000013702
Scientific Title Percutaneous cryoablation combined with transarterial embolization for treatment of renal cell carcinoma larger than 3 cm: Phase I/II clinical trial.
Date of disclosure of the study information 2013/11/07
Last modified on 2017/11/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Percutaneous cryoablation combined with transarterial embolization for treatment of renal cell carcinoma larger than 3 cm: Phase I/II clinical trial.
Acronym SCIRO-1301 study
Scientific Title Percutaneous cryoablation combined with transarterial embolization for treatment of renal cell carcinoma larger than 3 cm: Phase I/II clinical trial.
Scientific Title:Acronym SCIRO-1301 study
Region
Japan

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

Objectives
Narrative objectives1 The evaluation of safety and efficacy of percutaneous cryoablation combined with transarterial embolization
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

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

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Percutaneous cryoablation combined with transarterial embolization
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)Patients must be diagnosed with RCC by histology or cytology.
2)The tumor is measurable and its maximum diameter is >= 3.0 cm and <=7cm in diameter.
3)Patient has no indications 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 (>= 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 a attending physician.
Target sample size 21

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 2-5-2 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 2-5-2 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 Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 07 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 11 Month 06 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 06 Day
Last follow-up date
2019 Year 11 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 07 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=R000013702

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.