Thoracic Malignancies
Conditions
Interventions
Percutaneous cryoablation therapy using the Visual-ICE (Boston Scientific) for thoracic malignancies
Cryoablation
Sponsors
Asakura Keisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients for this study must meet all of the following criteria: 1) Thoracic Malignancies (with metastatic disease previously confirmed by prior biopsy or known (biopsied) primary disease): Patient with Stage4 pulmonary metastatic disease, Patient with recurrence tumor (primary lung cancer, malignant mediastinal tumor, malignant pleural tumor, malignant chest wall tumor) after the initial treatment. 2) Thoracic Malignancies without adaptation for the standard treatment: Patient who are not tolerable for surgery, Patient without adaptation for the radiotherapy because of the tumor location or the tumor with overlapping irradiation fields and retreating local progression after previous radiotherapy, Patient with tumor ineffective to radiotherapy and chemotherapy. 3) Patient has up to 3 tumors targetable by cryoablation. 4) Maximum size of tumor(s):Targeted tumor(s) defined as intrapulmonary with a maximum size of 3.5 cm, Targeted tumor(s) defined as mediastinal or pleural or chest wall with a maximum size of 10.0 cm. 5) Patient without uncontrollable primary or metastatic disease other than targeted tumor(s). 6) Patient must be 18 years or older, 79 years or younger. 7) ECOG performance status of 0-2. 8) Patients who are judged eligible for cryoablation by the interventional radiologists in charge of cryoablation, the thoracic surgeons in charge of cryoablation and surgery, the radiotherapists in charge of radiotherapy, and the pulmonologists in charge of chemotherapy. 9) The target tumor is determined to be technically achievable by the interventional radiologists in charge of cryoablation. 10) Patient has signed a written informed consent.
Exclusion criteria
Exclusion criteria: Patients not eligible for participation in this study include patients who have any of the following: 1) INR > 1.5 or platelet count < 50,000/mm3 within 28 days prior to registration. 2) Patient has had chemotherapy with neutropenia to levels (ANC < 1000/mm3) within 28 days prior to registration. 3) Patient has uncontrolled coagulopathy or bleeding disorders. 4) Patient has evidence of active systemic, pulmonary, or pericardial infection. 5) Patient is unable to lie flat. 6) Patient has respiratory distress at rest. 7) Patient with pregnancy. 8) Patient with active interstitial pneumonia. 9) Patients who are judged ineligible by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events of grade 3 or higher within 30 days post cryoablation | — |
Secondary
| Measure | Time frame |
|---|---|
| Local tumor control rate at one year post cryoablation, Overall survival, The incidence of Adverse events | — |
Contacts
Public ContactKaoru Kaseda
Keio University Hospital
Outcome results
None listed