NCT00042770CompletedPhase 3
Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC)
Alliance for Clinical Trials in Oncology2 sites in 1 country67 target enrollmentStarted: May 2002Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 67
- Locations
- 2
- Primary Endpoint
- Effusion control
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Effusion control
Time Frame: 30 days
Secondary Outcomes
- Quality of Life(7-14 days and 30-37 days)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Talc Pleurodesis: A Comparative Pilot Study Comparing Doctor vs Nurse Lead ProcedureISRCTN59686582Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Unknown
Early Phase 1
Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc PleurodesisPleural Effusion, MalignantLung NeoplasmsNCT02825095Rambam Health Care Campus120
Recruiting
Not Applicable
AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural EffusionRespiratory DiseaseCancerMalignant Pleural EffusionNCT04322136The University of Western Australia160
Completed
Phase 4
Thoracoscopic Talc Pleurodesis Versus Bleomycin -Tranxemic Acid Mixture Injection in Chest Tube in Malignant Pleural EffusionMalignant Pleural Effusions (Mpe)- PleurodesisPleurodesisNCT06744946Mohamed Sabry60
Completed
Not Applicable
Thoracentesis to Alleviate Cardiac Pleural EffusionHeart FailurePleural EffusionNCT05017753Bispebjerg Hospital135