UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012230 |
|---|---|
| Receipt number | 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 | 2023/08/10 14:11:20 |
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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 | Susumu |
| Middle name | |
| Last name | Kanazawa |
Organization
Okayama University Hospital
Division name
Department of Radiology
Zip code
7008558
Address
2-5-2 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
2-5-2 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
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Okayama Unicersity Hospital
Address
2-5-1 shikata-cho, kita-ku, Okayama
Tel
+81-86-235-6503
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10147-022-02224-7
Publication of results
Unpublished
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10147-022-02224-7
Number of participants that the trial has enrolled
19
Results
19 patients (mean age, 75 years; 5 women, 14 men) were prospectively enrolled.
Four grade 3 hematologic adverse events occurred, while no symptomatic grade 3 events occurred. The median follow up period was 68 (range 52 to 84) months. Two patients died from causes other than RCC. Overall survival, progression-free survival, and cause specific survival were 100%, 95%, and 100% at 3 years, and 95%, 84%, and 100% at 5 years, respectively.
Results date posted
| 2022 | Year | 10 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
adult patient with renal cell carcinoma of 3cm or more
Participant flow
recruiting among the patients with renal cell carcinoma visiting Okayama University Hospital
Adverse events
Four grade 3 hematologic adverse events occurred, while no symptomatic grade 3 events occurred. The median follow-up period was 68 (range 52-84) months.
Outcome measures
Adverse Event evaluated using CTCAEversion 4.0
OS, PFS and CSS rates
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 06 | Day |
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
| 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=R000013702
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