Lung Cancer, Metastatic Cancer
Conditions
Keywords
lung metastases, recurrent non-small cell lung cancer, recurrent small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer, pulmonary carcinoid tumor
Brief summary
RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment for primary lung cancer or lung metastases that cannot be removed by surgery. PURPOSE: This clinical trial is studying how well cryotherapy works in treating patients with primary lung cancer or lung metastases that cannot be removed by surgery.
Detailed description
OBJECTIVES: * Estimate the local and distant failure rates after percutaneous thoracic cryotherapy (PTC) in patients with unresectable primary lung cancer or lung metastases. * Estimate rates of PTC complications and adverse reactions. * Determine the correlations between procedural parameters and follow-up imaging parameters, with the latter being used as surrogates of local and/or distant treatment failure. OUTLINE: Patients undergo CT-guided percutaneous thoracic cryotherapy over 2 hours under local or general anesthesia. Grouped cryoprobes are inserted into the tumor, utilizing a freeze-thaw-freeze cycle, creating cytotoxic temperatures (less than -20°C to -40°C) that encompass the entire anticipated tumor volume. Patients undergo positron emission tomography at baseline and after cryotherapy to assess tumor standard uptake variable. After completion of study treatment, patients are followed at 1, 3, 6 and 12 months. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignant pulmonary neoplasm * New lung lesion(s) with definitive clinical and imaging features of primary or metastatic disease allowed * Imaging findings compatible with localized treatment failure after prior cryotherapy allowed * Malignant pleural effusion allowed provided it is associated with a distinct measurable pulmonary mass amenable to cryotherapy * Metastatic disease must meet all of the following criteria: * Primary tumors have been resected or have been deemed controlled by other therapies * No other widespread metastases evident (e.g., multiple hepatic or brain metastases) * Each pulmonary mass must be amenable to CT-guided percutaneous cryotherapy approach * No more than 5 targeted masses for study therapy * Target mass defined as pulmonary, hilar, mediastinal, and/or chest wall mass \> 1 cm, but \< 10 cm in average diameter * Unresectable disease by surgical consultation OR patient refused surgical options * Nonenhanced and enhanced CT scan required within the past 6 weeks done at 4-5 mm increments with available soft tissue and mediastinal windows to assess size and extent of all thoracic tumors * PET scan required within the past 6 months noting the correlation with the above CT locations, if not already obtained by a combined PET/CT scanner PATIENT CHARACTERISTICS: * Karnofsky performance status (PS) \> 60-100% OR WHO/ECOG/Zubrod PS 0-2 * FEV\_1 \> 30% of predicted * DLCO \> 40% of predicted * Platelet count ≥ 70,000/mm\^3 * INR \< 1.5 * No uncontrolled coagulopathy or bleeding diathesis * Not pregnant or nursing * Negative pregnancy test * No serious medical illness, including any of the following: * Uncontrolled congestive heart failure * Uncontrolled angina * Myocardial infarction * Cerebrovascular event within 6 months prior to study entry * No medical contraindication or potential problem that would preclude study compliance PRIOR CONCURRENT THERAPY: * At least 7 days since prior aspirin and aspirin-like medications * At least 3 days since prior warfarin, clopidogrel bisulfate, or similar compounds * No concurrent drugs causing bleeding tendencies (e.g., aspirin, warfarin, or clopidogrel bisulfate) * No concurrent participation in other experimental studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Failure Rates by CT Scan | at 3, 6, and 12 months | Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence |
| Distant Failure Rate | at 3, 6, and 12 months | Distant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Complications and Adverse Reactions by Occurrences of Toxicities | at 3, 6, and 12 months | Rate of complications and adverse reactions by occurrences of toxicities as measured by the number of participants with a given category of toxicity. |
| Correlate Procedural Parameters and Follow-up Imaging Parameters | at 3, 6, and 12 months | — |
| Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures | 12 months after the last patient was enrolled | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cryosurgery cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
cryosurgery
positron emission tomography | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Cryosurgery |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 21 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 38 / 40 |
| serious Total, serious adverse events | 9 / 40 |
Outcome results
Distant Failure Rate
Distant Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Time frame: at 3, 6, and 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cryosurgery | Distant Failure Rate | 52.5 % of participants |
Local Failure Rates by CT Scan
Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
Time frame: at 3, 6, and 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cryosurgery | Local Failure Rates by CT Scan | 15 % of participants |
Correlate Procedural Parameters and Follow-up Imaging Parameters
Time frame: at 3, 6, and 12 months
Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures
Time frame: 12 months after the last patient was enrolled
Rate of Complications and Adverse Reactions by Occurrences of Toxicities
Rate of complications and adverse reactions by occurrences of toxicities as measured by the number of participants with a given category of toxicity.
Time frame: at 3, 6, and 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | DVT | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | atelectasis | 3 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | constipation | 2 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | contact dermatitis | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | deconditioning | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | depression | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | epigastric pain | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | fatigue | 3 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | hemothorax | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | insomnia | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | muscle spasm | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | pain right side | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | severe atrial flutter | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | Anemia | 7 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | Chest Wall Pain | 21 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | Cough | 6 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | Dyspnea | 7 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | Elevated AST | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | Hemoptysis | 8 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | Hemorrhagic Effusion | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | Hypotension | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | Hypoxia | 2 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | Pleural Effusion | 21 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | Pneumothorax | 21 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | Pulmonary Hemorrhage | 16 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | anxiety | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | blister | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | blurriness of vision | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | bradycardia | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | cardiac arrest | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | elevated ALT | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | headache | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | heartburn/dyspepsia | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | hepatic arteriovenous fistula | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | hyperglycemia | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | hypertension | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | ileus | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | infection | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | infection with normal ANC | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | low phosphorous | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | lymphopenia | 3 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | nausea | 2 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | pain | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | pneumonitis | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | progressive weakness | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | respiratory failure | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | subcutaneous hematoma | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | thrombocytopenia | 1 Participants |
| Cryosurgery | Rate of Complications and Adverse Reactions by Occurrences of Toxicities | vomiting | 2 Participants |