Metastatic Cancer Clinical Trial
Official title:
Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC)
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.
Status | Completed |
Enrollment | 67 |
Est. completion date | February 2008 |
Est. primary completion date | February 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Providence Saint Joseph Medical Center - Burbank | Burbank | California |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effusion control | 30 days | No | |
Secondary | Quality of Life | 7-14 days and 30-37 days | No |
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