Percutaneous cryoablation of renal cell carcinoma smaller than 4 cm: Phase II clinical trial

Percutaneous cryoablation of renal cell carcinoma smaller than 4 cm: Phase II clinical trial - SCIRO-1302 study

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000011921

Enrollment

Registered

2013-10-01

Start date

2013-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal cell carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Cause specific survival (CSS)	—

Secondary

Measure	Time frame
Frequency of adverse events Overall survival(OS) Local progression rate Recurrence free survival (RFS) Imaging findings	—

Countries

Japan

Contacts

Public ContactHideo Gobara

Okayama University Hospital Department of Radiology

gobara@cc.okayama-u.ac.jp+81-86-235-7315

Outcome results