Talc in Treating Patients With Malignant Pleural Effusion
Condition: Metastatic Cancer
MeSH terms: Pleural Effusion, Malignant; Pleural Effusion
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): talc; Talc
Intervention type(s): Drug; Drug
Intervention description(s): 4 to 5 grams talc in 100 cc saline via chest tube at bedside, one time; 4 to 5 grams talc via insufflation through direct or video thoracoscopy, one time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: malignant pleural effusion