Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis (NCT00890617) | Clinical Trial Compass
CompletedPhase 1
Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis
United States9 participantsStarted 2009-03
Plain-language summary
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.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
The Number of Patients With a Response (Complete Response and Partial Response)