Talc in Treating Patients With Malignant Pleural Effusion

Phase 3

Completed

• Conditions: Metastatic Cancer
• Interventions: Drug: Talc

• Registration Number: NCT00002622
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Study Timeline

• Study Start: 1994-12
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-08-30
• Study First Posted: 2004-08-31
• Primary Completion: 2005-03
• Study Completion: 2006-01
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-27
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Talc via insufflation	Talc	4 to 5 grams talc via insufflation through direct or videoscopic thoracoscopy, one time
Talc slurry via chest tube	Talc	talc slurry via chest tube

Primary Outcome Measures

Name	Time	Method
Successful pleurodesis	30 days
Cost and cost effectiveness	30 days	cost and cost effectiveness of treating malignant pleural effusions

Secondary Outcome Measures

Name	Time	Method
Complications and toxicity	6 months
Time to recurrence of effusion	6 months

Trial Locations

Locations (241)

Veterans Affairs Medical Center - Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Alabama Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Huntsville Hospital System; 🇺🇸 Huntsville, Alabama, United States

Urology Associates - Mobile AL; 🇺🇸 Mobile, Alabama, United States

MBCCOP - University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Alabama Oncology, LLC; 🇺🇸 Montgomery, Alabama, United States

Radiation Oncology Associates of West Alabama; 🇺🇸 Tuscallosa, Alabama, United States

Providence Cancer Therapy Center; 🇺🇸 Anchorage, Alaska, United States

CCOP - Scottsdale Oncology Program; 🇺🇸 Scottsdale, Arizona, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

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