Lung Cancer, Metastatic Cancer
Conditions
Keywords
lung metastases, stage I non-small cell lung cancer
Brief 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.
Detailed description
OBJECTIVES: Primary * Evaluate the histologic result of treating patients with primary stage I non-small cell lung cancer or lung metastasis after neoadjuvant percutaneous cryotherapy (PTC). Secondary * Provide a qualitative assessment of the histology from the ablation and tumor margins, comparing histologic observations with imaging-enhancement patterns by CT or PET scan before and after PTC. OUTLINE: Patients undergo CT-guided percutaneous cryotherapy (PTC) over 2 hours. Approximately 3 weeks after completion of PTC, patients undergo thoracotomy consisting of lobectomy of the primary lung cancer or wedge resection with adequate margin for the metastatic lesion, and mediastinal lymph node dissection. Tissue samples from ablation and tumor margins are collected during thoracotomy and compared with imaging-enhanced patterns of CT or PET scans taken at baseline and after PTC. After completion of study therapy, patients are followed periodically for 6 months.
Interventions
CT-guided PTC with the intent to eradicate the entire tumor(s).
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
Sponsors
Study design
Eligibility
Inclusion criteria
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 studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients With a Response (Complete Response and Partial Response) | 3 weeks post-Percutaneous Cryotherapy (PTC) | 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
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients With a Pathologic Response | 6 months post-Percutaneous Cryotherapy (PTC) | Histology samples from anterior, posterior, superior, inferior, medial and lateral areas of the resected tumor will be compared to enhancement zones of the ablation margin for any residual cancer. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prednisone & Cryotherapy 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
Cryotherapy (PTC): CT-guided PTC with the intent to eradicate the entire tumor(s).
Prednisone: 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 | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Prednisone & Cryotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 65.78 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 9 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 9 |
| other Total, other adverse events | 9 / 9 |
| serious Total, serious adverse events | 2 / 9 |
Outcome results
The Number of Patients With a Response (Complete Response and Partial Response)
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).
Time frame: 3 weeks post-Percutaneous Cryotherapy (PTC)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisone & Cryotherapy | The Number of Patients With a Response (Complete Response and Partial Response) | 8 Participants |
The Number of Patients With a Pathologic Response
Histology samples from anterior, posterior, superior, inferior, medial and lateral areas of the resected tumor will be compared to enhancement zones of the ablation margin for any residual cancer.
Time frame: 6 months post-Percutaneous Cryotherapy (PTC)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prednisone & Cryotherapy | The Number of Patients With a Pathologic Response | macroscopic residual viable tumor | 1 Participants |
| Prednisone & Cryotherapy | The Number of Patients With a Pathologic Response | microscopic foci of viable tumor | 2 Participants |
| Prednisone & Cryotherapy | The Number of Patients With a Pathologic Response | no microscopic viable tumor | 6 Participants |