Trial Information

Sclerosis of Pleural Effusions by Talc Thoracoscopy Versus Talc Slurry: A Phase III Study

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.