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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA022453 | U.S. NIH Grant/Contract | View source | |
| WSU-2008-048 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone & Cryotherapy | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryotherapy (PTC) | Procedure | CT-guided PTC with the intent to eradicate the entire tumor(s). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 weeks post-Percutaneous Cryotherapy (PTC) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post-Percutaneous Cryotherapy (PTC) |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed (by percutaneous transthoracic needle biopsy or transbronchial biopsy) diagnosis of 1 the following:
Non-small cell lung carcinoma
Metastatic cancer to the lung
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Frank A. Baciewicz, MD | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
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| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Count of Participants | Participants | 3 weeks post-Percutaneous Cryotherapy (PTC) |
|
over the first 6 months of study
CTCAE criteria
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| aspergillosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frank A. Baciewicz | Barbara Ann Karmanos Cancer Institute | (313) 993-0580 | FBaciewi@dmc.org; baciewic@karmanos.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2012 | Jul 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009362 | Neoplasm Metastasis |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Prednisone | Drug | 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 |
|
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 6 months post-Percutaneous Cryotherapy (PTC) |
|
|
|
| 2 |
| 9 |
| 2 |
| 9 |
| 9 |
| 9 |
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| pneumonia | Infections and infestations | Systematic Assessment |
|
| atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| vocal cord dysfunction | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |