UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011921 |
|---|---|
| Receipt number | R000013906 |
| Scientific Title | Percutaneous cryoablation of renal cell carcinoma smaller than 4 cm: Phase II clinical trial |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2023/08/10 14:11:44 |
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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
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) 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 (>=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 | Susumu |
| Middle name | |
| Last name | Kanazawa |
Organization
Okayama University Hospital
Division name
Department of Radiology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
+81-86-235-7315
susumu@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideo |
| Middle name | |
| Last name | Gobara |
Organization
Okayama University Hospital
Division name
Department of Radiology
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
+81-86-235-7315
Homepage URL
gobara@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1, shikata-cho, kita-ku, Okayama city
Tel
086-235-6938
mae6605@adm.okayama-u.ac.jp
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
https://pubmed.ncbi.nlm.nih.gov/33174078/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33174078/
Number of participants that the trial has enrolled
33
Results
The mean tumor diameter: 2.1 +/- 0.6 (range 1.0-3.4) cm.
The median follow up period: 60.1 (range 18.4-76.6) months.
The cause specific and overall survival rates were 100% and 96.8% at 3 years, and 100% and 96.8% at 5 years, respectively.
There was no local tumor progression or distant metastasis.
Results date posted
| 2022 | Year | 04 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patient with renal cell carcinoma of 4cm or smaller diameter
Participant flow
Regular follow-up after cryotherapy for at least 36 months, then every 12 months as much as possible
Adverse events
The incidence of severe urological (urinary fistula and perinephric infection) and non-urological adverse events (increased creatine kinase and skin ulceration) was 6% each.
Outcome measures
CSS/OS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
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
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013906
