Clinical trial · Interventional
Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis
A Pilot Study of Percutaneous Cryotherapy as Treatment for Stage I Lung Cancer or Solitary Metastatic Lung Cancer
NCT00890617CI-TRIAL-00061868completedPhase 1Results postedClinicalTrials.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)
RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving cryotherapy before surgery may kill more tumor cells. PURPOSE: This phase I trial is studying how well cryotherapy works in treating patients with primary stage I non-small cell lung cancer or lung metastasis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryotherapy (PTC) | Procedure | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prednisone & Cryotherapy
- description
- Prednisone taken: 20mg BID on the day of the cryotherapy procedure 20mg BID on the day after the procedure 20mg BID two days after the procedure 20mg AM and 10mg PM three days after the procedure 10mg AM and 10mg PM four days after the procedure 10mg five days after the procedure 5mg six days after the procedure
- interventionNames
- Procedure: Cryotherapy (PTC)
- Drug: Prednisone
Primary outcomes (1)
- measure
- The Number of Patients With a Response (Complete Response and Partial Response)
- timeFrame
- 3 weeks post-Percutaneous Cryotherapy (PTC)
- description
- Treatment success was defined as \> 75% of the resected ablated tissue showing no cancer on detailed histologic analysis. The primary statistical objective was to estimate the PCA success rate (p).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed (by percutaneous transthoracic needle biopsy or transbronchial biopsy) diagnosis of 1 the following:
* Non-small cell lung carcinoma
* Stage I disease
* Primary disease
* No primary lung metastatic disease, satellite lesions of the chest, mediastinal lymph nodes \> 1.5 cm, hepatic or adrenal masses by the PET scan or the CT scan
* Metastatic cancer to the lung
* Must have a definitive cancer diagnosis with the primary tumor under local control and no metastatic disease other than to the lung
* Solitary or multiple (≤ 3) peripheral lung lesions
* No chemotherapy since the new metastatic lesion appeared
* Measurable disease, defined as 1 lesion unidimensionally measured ≤ 3.0 cm by conventional CT scan techniques
* Must be registered with the Clinical Trials office at the Karmanos Cancer Center/Wayne State University
* Must be a candidate for a thoracotomy
* No evidence of cerebral disease or metastatic disease of the brain
PATIENT CHARACTERISTICS:
* Neutrophil count \> 1,500/mm\^3
* Platelet count \> 75,000/mm\^3
* PT and PTT normal
* FEV\_1 \> 1.0 L/sec
* Diffusing capacity ≥ 30%
* Not pregnant or nursing
* No other uncontrolled or concurrent illnesses including, but not limited to, any of the following conditions:
* Active infection
* Heart failure
* Unstable angina
* Cardiac dysrhythmia
* Psychiatric illness or a social situation that would limit compliance with the study requirements
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior radiation therapy or chemotherapy for these particular tumors
* No concurrent aspirin or other platelet-inhibiting drugs (e.g., coumadin or heparin)
* No other concurrent experimental studiesReferences
Publications (0)
Data not yet available
No reference posted for this study.