Clinical trial · Interventional
Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body
A Pilot Study of Cryoablation for Patients With Oligometastatic Cancer Involving the Lung
NCT01325753CI-TRIAL-00033592withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This pilot clinical trial studies the side effects of cryotherapy (cryoablation \[CA\]) in treating patients with lung cancer. Cryotherapy kills cancer cells by freezing them.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Mesothelioma | Malignant Mesothelioma | CURATED_BROADER | 0.78 |
| Extensive Stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Lung Metastases | — | UNRESOLVED | — |
| Recurrent Malignant Mesothelioma | Malignant Mesothelioma | CURATED_BROADER | 0.78 |
| Recurrent Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cryotherapy | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (cryoablation)
- description
- Patients undergo CT-guided CA.
- interventionNames
- Procedure: cryotherapy
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- Safety of interventional cryoablation to the lung
- timeFrame
- 6 months
- description
- Unexpected toxiticities or Grade 4 or 5 toxicities will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
Secondary outcomes (4)
- measure
- Local control measured by imaging
- timeFrame
- At 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with American Joint Committee on Cancer (AJCC) seventh edition metastatic carcinoma or sarcoma involving the lungs or pleura. * Pathologic diagnosis of stage 4 cancer prior to enrollment by biopsy or on imaging with known (biopsied) primary disease * The target lesion is determined (by CT or magnetic resonance imaging \[MRI\] images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures * Maximum number of lesions per patient will be 5 total (a maximum of 3 on either the right or left side and 2 lesions on the respective contralateral side) * Of these, any lesion not treated with cryoablation will be planned to be treated with radiotherapy or radiofrequency ablation, such that all known active pulmonary disease is planned to be treated with a definitive local therapy * If treatment of both lungs is to occur by cryoablation, these treatments must be separated by at least one week * The lesion(s) treated with cryoablation may be intrapulmonary or pleural and must be =\< 3.5 cm in greatest dimension * All patients are required to have been evaluated either in consultation with a radiation oncologist or at least in a multi-disciplinary tumor conference to ensure that all local therapy options are appropriately considered for each patient * Performance Status 0-2 (Eastern Cooperative Oncology Group \[ECOG\]); Karnofsky Performance Scale \>= 60 * Life expectancy \> 3 months * Clinically suitable for cryoablation procedure as determined by the treating physician * Platelet count \> 50,000/mm\^3 within 60 days prior to study registration * International normalized ratio (INR) \< 1.5 within 60 days prior to study registration * Absolute neutrophil count (ANC) \< 1000 within 21 days prior to study registration * A signed study specific consent form is required Exclusion Criteria: * Primary lung cancer * Unable to lie flat or has respiratory distress at rest * Uncontrolled coagulopathy or bleeding disorders * Evidence of active systemic, pulmonary, or pericardial infection * Pregnant, nursing or wishes to become pregnant during the study * Debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up * Currently participating in other experimental studies that could affect the primary endpoint
References
Publications (0)
Data not yet available
No reference posted for this study.