N/A
N=131
Study of Cryoablation for Metastatic Lung Tumors
Neoplasm Metastasis
Bottom Line
View on ClinicalTrials.gov: NCT01957787 ↗Enrolled (actual)
131
Serious AEs
13.9%
Results posted
Aug 2019
Primary outcome: Primary: Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 12 — 84.6 percentage of tumors — p=0.410
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cryoablation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 12 |
84.6 | 0.410 |
| SECONDARY Number of Participants With an Intra- or Post-operative Adverse Event, a Serious Adverse Event, or an Unanticipated Adverse Device Effect |
39; 18; 15; 4; 4; 0 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in participants with pulmonary metastatic disease. This study is to enroll participants who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 centimeter (cm). Participants will be followed 24 months post their cryoablation procedure.
Eligibility Criteria
Inclusion Criteria
- Participant must be at least 18 years old.
- Participant has signed a written informed consent.
- Participant presents with Stage 4 pulmonary metastatic disease with metastatic disease previously confirmed by prior biopsy; or Participant presents with Stage 4 pulmonary metastatic disease previously confirmed on imaging (for example, computerized tomography or CT) with histology proven primary cancer.
- Participant has up to 6 local pulmonary metastases targetable by cryoablation.
- Targeted index tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm, measured in the longest cross-sectional dimension.
- The target index tumor(s) is determined (by CT images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs/ structures and is greater than 0.5 cm from any critical organ/structure (possibly achieved with additional maneuvers such as iatrogenic pneumothorax or hydrodissection).
- Karnofsky Performance Scale (KPS) score greater than or equal to 60.
- Platelet count greater than 50, 000/millimeters (mm)^3 within 8 weeks prior to initial cryoablation procedure.
- International Normalized Ratio (INR) less than 1.5 within 8 weeks prior to initial cryoablation procedure.
- Participant has a life expectancy of greater than 3 months.
Exclusion Criteria
- Participant's index tumor(s) is primary lung cancer.
- Participant has uncontrollable primary or metastatic disease outside of the lung.
- Participant is unable to lie flat or has respiratory distress at rest.
- Participant has a coagulopathy or bleeding disorder which is uncontrolled.
- Absolute Neutrophil Count (ANC) <1000 within 8 weeks prior to initial cryoablation procedure.
- Participant has evidence of active systemic, pulmonary, or pericardial infection.
- Participant has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.
- Participant is currently participating in other experimental studies that could affect the primary endpoint (for example, experimental chemotherapy regimen).
Data sourced from ClinicalTrials.gov (NCT01957787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.