CompletedPhase 3NCT00042770

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

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.

Checked against the public recordLast updated Jul 4, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations1
SponsorAlliance for Clinical Trials in Oncology
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Other: talc; Procedure: dyspnea management
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

DISEASE CHARACTERISTICS: * Radiologic evidence of a unilateral malignant pleural effusion requiring sclerosis or ongoing drainage because it is symptomatic (dyspnea and/or progressive fatigue) * An asymptomatic patient is eligible if the patient underwent a prior thoracentesis within the past 2 weeks and was symptomatic before the procedure * No bilateral effusions by plain chest x-ray * Histologically or cytologically confirmed solid tumor or hematologic malignancy * Histologic confirmation of malignant cells in pleural fluid is not required * Pleural spaces must be naive to pleurodesis attempts * No prior intrapleural therapy (defined as a chest tube in place or placed to drain an effusion, prior surgical pleurectomy, or any prior chemical or mechanical pleurodesis on the ipsilateral side) * Placement of a small interventional radiology catheter for temporary drainage is not considered intrapleural therapy as long as no sclerosant medication was given and it has not been in place longer than 10 days PATIENT CHARACTERISTICS: Age * 18 and over Performance status * CTC 0-2 Hematopoietic * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Pulmonary * No active pleural infection Other * No allergy to talc * No surgical contraindication to talc usage * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Chemotherapy * Concurrent systemic chemotherapy allowed Radiotherapy * Concurrent palliative radiotherapy to a symptomatic lesion allowed except to the treated hemithorax within 30 days of the drainage procedure Surgery * See Disease Characteristics * Prior thoracotomies without specific pleural ablation (including lobectomy but not pneumonectomy) allowed * Prior needle-based diagnostic interventions (fine-needle aspiration, small bore catheter drainage of less than 10 days, or thoracentesis) allowed

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Providence Saint Joseph Medical Center - BurbankBurbank, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 4, 2016. Always confirm current availability with the study team.

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