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

Phase 3
18 Years
Not Enrolling
Metastatic Cancer

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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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Unilateral malignant pleural effusion requiring sclerosis (as
judged by the attending surgeon) At least 3 months since treatment of contralateral
effusion No chylous effusion

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
More than 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: Able to undergo thoracoscopy under general or local anesthesia (as
determined by the attending surgeon) Not pregnant Tests and observations must be completed
within 1 week prior to randomization (chest x-ray within 1 week prior to procedure)

PRIOR CONCURRENT THERAPY: No prior intrapleural therapy No systemic therapy within 2 weeks
prior to randomization or 2 weeks post pleurodesis Biologic therapy: Not specified
Chemotherapy: No new systemic chemotherapy for 2 weeks prior to and at least 2 weeks after
pleurodesis Endocrine therapy: No new hormonal therapy for 2 weeks prior to and at least 2
weeks after pleurodesis No concurrent steroids used as antiemetics Radiotherapy: Prior
radiotherapy allowed No radiotherapy to entire hemithorax Palliative irradiation of
symptomatic bone lesions allowed on the affected side if field does not include a
significant portion of pleura Surgery: See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Successful pleurodesis

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator

Jemi Olak, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kern Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 1994

Completion Date:

January 2006

Related Keywords:

  • Metastatic Cancer
  • malignant pleural effusion
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Pleural Effusion
  • Pleural Effusion, Malignant



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