renal cell carcinoma (RCC)
Conditions
Interventions
Percutaneous cryoablation combined with transarterial embolization
Sponsors
Okayama University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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.
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 a attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Cause specific survival (CSS) Overall survival(OS) Local progression rate Recurrence free survival (RFS) Imaging findings | — |
Countries
Japan
Contacts
Public ContactHideo Gobara
Okayama University Hospital Department of Radiology
Outcome results
None listed