Talc in Treating Patients With Malignant Pleural Effusion
RATIONALE: Talc may relieve malignant pleural effusion. It is not yet known whether wet talc is more effective than dry talc in treating patients with malignant pleural effusion.
PURPOSE: Randomized phase III trial to compare the effectiveness of wet talc with dry talc in treating patients with malignant pleural effusion.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Sclerosis of Pleural Effusions by Talc Thoracoscopy Versus Talc Slurry: A Phase III Study|
- Successful pleurodesis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Cost and cost effectiveness [ Time Frame: 30 days ] [ Designated as safety issue: No ]cost and cost effectiveness of treating malignant pleural effusions
- Time to recurrence of effusion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Complications and toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 1994|
|Study Completion Date:||January 2006|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
Active Comparator: Talc slurry via chest tube
talc slurry via chest tube
4 to 5 grams talc in 100 cc saline via chest tube at bedside, one time
Active Comparator: Talc via insufflation
4 to 5 grams talc via insufflation through direct or videoscopic thoracoscopy, one time
4 to 5 grams talc via insufflation through direct or video thoracoscopy, one time
OBJECTIVES: I. Compare the proportion of patients with successful pleurodesis at 30 days following treatment for malignant pleural effusion (MPE) by talc slurry via chest tube vs thoracoscopic talc insufflation. II. Compare the cost and cost effectiveness of both treatments for MPE. III. Compare the time to recurrence of effusion, duration of chest tube drainage after sclerosis, extent of postinstillation complications and toxicities, and the ability to re-expand the lung in patients randomized to these 2 treatments. IV. Evaluate the quality of life and pain experienced by patients during both treatments.
OUTLINE: This is a randomized study. Patients are stratified according to participating institution. Patients are randomized to one of two treatment arms. Arm I: Patients undergo pleurodesis. A chest tube is inserted, the pleural fluid is drained for 24 hours, and the lung is re-expanded to at least 90% of full expansion. Within 24-36 hours patients undergo sclerosis with talc slurry injected into the chest tube, which is then clamped. Patients are rotated in all possible directions, holding each position for about 30 minutes. After 2 hours the chest tube is unclamped and reattached to suction drainage, which is strictly measured for 24-hour totals. Following a decrease in drainage to no more than 150 ml/24 hours (usually by the second or third day postsclerosis), the chest tube is removed. Arm II: Patients receive thoracoscopic insufflation. The chest is explored thoracoscopically via single or multiple incisions using direct or videothoracoscopic visualization, and the lung is re-expanded to 90% of full expansion. Dry talc is pneumatically insufflated into the chest, with complete dispersion throughout the hemithorax. Following insufflation, the chest is drained via a chest tube, which is removed when the drainage is no more than 150 ml/24 hours (usually by day 2 or 3 following insufflation). Patients are removed from study for disease progression or an unsuccessful lung re-expansion. Patients are followed monthly for 6 months for relapse and survival.
PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study over 28 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002622
Show 241 Study Locations
|Study Chair:||Jemi Olak, MD||Kern Medical Center|
|Study Chair:||Thomas M. Daniel, MD||University of Virginia|
|Study Chair:||George B. Haasler, MD||Froedtert Hospital and Medical College of Wisconsin|
|Study Chair:||Mark S. Allen, MD||Mayo Clinic|