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.
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 4, 2016 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
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.