![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000011921 |
Receipt No. | 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 | 2017/11/10 |
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 |
|
Condition | |||
Condition | renal cell carcinoma | ||
Classification by specialty |
|
||
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 | ||||||
susumu@cc.okayama-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
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 | |||||||
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 | |
Registered date | File name |
Research case data | |
Registered date | File name |