Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer

Phase 3

Completed

• Conditions: Metastatic Cancer; Pulmonary Complications
• Interventions: Other: talc; Procedure: dyspnea management

• Registration Number: NCT00042770
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: It is not yet known whether pleurodesis using a chest tube with infusions of talc is more effective in improving quality of life than pleurodesis using a small catheter in treating malignant pleural effusion.

PURPOSE: Randomized phase III trial to compare the effectiveness of a chest tube and talc with that of a small catheter in treating malignant pleural effusion in patients who have cancer.

Detailed Description

OBJECTIVES:

* Compare the success rate in patients with cancer who undergo pleurodesis using a standard chest tube with talc slurry vs a small (PleurX) catheter for the treatment of a symptomatic unilateral malignant pleural effusion.

* Compare the 30-day effusion control rate in patients treated with these procedures.

* Compare quality of life in these patients at 7-14 and 30-37 days after treatment with these procedures.

* Compare patient acceptance and satisfaction after treatment with these procedures.

* Compare the level of symptoms and dyspnea experienced by patients treated with these procedures.

* Compare the types, causes, and rates of early technical failures of these procedures in these patients.

* Compare the 30-day effusion recurrences in patients treated with these procedures.

* Compare the 60-day durability of pleurodesis in patients treated with these procedures.

* Compare the mortality, morbidity, and common surgical complications in patients treated with these procedures.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to inpatient status (yes vs no), disease type (breast vs lung vs other), and concurrent systemic chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo placement of a standard pleural chest tube. Within 36 hours of chest tube placement, patients undergo pleurodesis comprising intrapleural administration of talc slurry once followed by clamping of the chest tube for 2 hours while different patient positions are used to distribute the talc. The chest tube is then unclamped to allow continuous drainage. When the chest tube drainage is less than 150 mL over 24 hours, pleurodesis is assumed and the chest tube is removed.

* Arm II: Patients undergo pleurodesis comprising placement of a small (PleurX) catheter followed by pleural drainage for up to 90 minutes once daily. When the catheter drainage is less than 30 mL per day for 3 consecutive days, pleurodesis is assumed and the catheter is removed.

Quality of life and dyspnea are assessed at baseline and then at 7-14 and 30-37 days after treatment.

Patients are followed at 30 and 60 days.

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-08-05
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-02
• Study Completion: 2008-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-01
• Last Update Posted: 2016-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	talc	Patients undergo placement of a standard pleural chest tube. Within 36 hours of chest tube placement, patients undergo pleurodesis comprising intrapleural administration of talc slurry once followed by clamping of the chest tube for 2 hours while different patient positions are used to distribute the talc. The chest tube is then unclamped to allow continuous drainage. When the chest tube drainage is less than 150 mL over 24 hours, pleurodesis is assumed and the chest tube is removed.
Arm II	dyspnea management	Patients undergo pleurodesis comprising placement of a small (PleurX) catheter followed by pleural drainage for up to 90 minutes once daily. When the catheter drainage is less than 30 mL per day for 3 consecutive days, pleurodesis is assumed and the catheter is removed.

Primary Outcome Measures

Name	Time	Method
Effusion control	30 days

Secondary Outcome Measures

Name	Time	Method
Quality of Life	7-14 days and 30-37 days

Trial Locations

Locations (1)

Providence Saint Joseph Medical Center - Burbank; 🇺🇸 Burbank, California, United States