N/A
N=40
Safety and Efficacy of Cryoablation for Metastatic Lung Tumors
Metastatic Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01307501 ↗Enrolled (actual)
40
Serious AEs
15.0%
Results posted
Oct 2019
Primary outcome: Primary: Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60 — 80.0; 45.0; 15.0; 20.0 percentage of tumors
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
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60 |
80.0; 45.0; 15.0; 20.0; 20.0 | — |
| SECONDARY Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48 |
46.4; 66.7; 80.4; 87.5; 90.9; 90.3 | — |
| SECONDARY Overall Disease-Specific Participant Survival Post-Cryoablation |
100; 100; 100; 100; 100; 86.5 | — |
| SECONDARY Time in Days to Disease Recurrence or Progression Following Study Cryoablation |
0; 0; 0; 0; 2.5; 5.1 | — |
| SECONDARY Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60 |
0.1; 0; 0.2; 0.1; 0.2; 0.2 | — |
| SECONDARY Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60 |
95.5; -1.8; -0.9; -1.6; 0.3; -0.5 | — |
| SECONDARY Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60 |
-10.0; -12.0; -12.5; -23.9; -10.4; -12.5 | — |
| SECONDARY Cryoablation Technical Success of the Study Cryoablation Procedure |
100 | — |
| SECONDARY Number of Participants With an Intra- or Post-operative Adverse Event (AE), a Serious AE, or an Unanticipated Adverse Device Effect (UADE) |
23; 9; 19; 6; 0 | — |
| SECONDARY Metastatic Disease Spread as Measured by Imaging |
16; 14; 14; 10; 9; 7 | — |
Summary
ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors less than or equal to 3.5 centimeters (cm) in participants with pulmonary metastatic disease.
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 confirmed on imaging with known primary disease.
- Participant has up to 3 local metastases unilaterally targeted by cryoablation. Maximum of 5 total pulmonary tumors bilaterally.
- Targeted tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm.
- The target tumor is determined (by CT/MRI) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures.
- Eastern Cooperative Oncology Group (ECOG) score of 0-2.
- Karnofsky Performance Scale (KPS) score ≥60.
- Platelet count >50, 000/cubed millimeters (mm^3) within 60 days prior to study treatment.
- International normalized ratio (INR) less than 1.5 within 60 days prior to study treatment.
- Participant has a life expectancy of >3 months.
- Participant is clinically suitable for cryoablation procedure.
Exclusion Criteria
- Participant's primary cancer is lung cancer.
- Participant is unable to lie flat or has respiratory distress at rest.
- Participant has uncontrolled coagulopathy or bleeding disorders.
- Participant has had chemotherapy with neutropenia to levels as confirmed by absolute neutrophil count (ANC) of less than 1000 that produce increase risk for the cryoablation procedure.
- Participant has a history of an allergic reaction to iodine injections or to shellfish.
- 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.
Data sourced from ClinicalTrials.gov (NCT01307501). 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.