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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA076001 | U.S. NIH Grant/Contract | View source | |
| CALGB-30102 | |||
| CDR0000069451 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: It is not yet known whether pleurodesis using a chest tube with infusions of talc is more effective in improving quality of life than pleurodesis using a small catheter in treating malignant pleural effusion.
PURPOSE: Randomized phase III trial to compare the effectiveness of a chest tube and talc with that of a small catheter in treating malignant pleural effusion in patients who have cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to inpatient status (yes vs no), disease type (breast vs lung vs other), and concurrent systemic chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Quality of life and dyspnea are assessed at baseline and then at 7-14 and 30-37 days after treatment.
Patients are followed at 30 and 60 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Active Comparator | Patients undergo placement of a standard pleural chest tube. Within 36 hours of chest tube placement, patients undergo pleurodesis comprising intrapleural administration of talc slurry once followed by clamping of the chest tube for 2 hours while different patient positions are used to distribute the talc. The chest tube is then unclamped to allow continuous drainage. When the chest tube drainage is less than 150 mL over 24 hours, pleurodesis is assumed and the chest tube is removed. |
|
| Arm II | Experimental | Patients undergo pleurodesis comprising placement of a small (PleurX) catheter followed by pleural drainage for up to 90 minutes once daily. When the catheter drainage is less than 30 mL per day for 3 consecutive days, pleurodesis is assumed and the catheter is removed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| talc | Other | Given intrapleurally |
| |
| dyspnea management |
| Measure | Description | Time Frame |
|---|---|---|
| Effusion control | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | 7-14 days and 30-37 days |
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DISEASE CHARACTERISTICS:
Radiologic evidence of a unilateral malignant pleural effusion requiring sclerosis or ongoing drainage because it is symptomatic (dyspnea and/or progressive fatigue)
Histologically or cytologically confirmed solid tumor or hematologic malignancy
Pleural spaces must be naive to pleurodesis attempts
No prior intrapleural therapy (defined as a chest tube in place or placed to drain an effusion, prior surgical pleurectomy, or any prior chemical or mechanical pleurodesis on the ipsilateral side)
PATIENT CHARACTERISTICS:
Age
Performance status
Hematopoietic
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Todd Demmy, MD | Roswell Park Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Saint Joseph Medical Center - Burbank | Burbank | California | 91505 | United States |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013627 | Talc |
| ID | Term |
|---|---|
| D017633 | Magnesium Silicates |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D017640 | Silicates |
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| Procedure |
No talc |
|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D008903 |
| Minerals |
| D012824 | Silicic Acid |
| D012822 | Silicon Dioxide |
| D017655 | Silicon Compounds |