Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer
This study has been completed.
Sponsor:
Cancer and Leukemia Group B
Collaborator:
Information provided by:
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00042770
First received: August 5, 2002
Last updated: March 31, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasm Metastasis Pulmonary Complications |
Other: talc Procedure: dyspnea management |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC) |
Resource links provided by NLM:
Further study details as provided by Cancer and Leukemia Group B:
Primary Outcome Measures:
- Effusion control [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of Life [ Time Frame: 7-14 days and 30-37 days ] [ Designated as safety issue: No ]
| Enrollment: | 67 |
| Study Start Date: | May 2002 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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.
|
Other: talc
Given intrapleurally
|
|
Experimental: 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.
|
Procedure: dyspnea management
No talc
|
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.
PROJECTED ACCRUAL: A total of 530 patients (265 per treatment arm) will be accrued for this study within 3.5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Not specified
Renal
- Not specified
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:
Biologic therapy
- Not specified
Chemotherapy
- Concurrent systemic chemotherapy allowed
Endocrine therapy
- Not specified
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042770
Locations
| United States, California | |
| Providence Saint Joseph Medical Center - Burbank | |
| Burbank, California, United States, 91505 | |
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
| Study Chair: | Todd L. Demmy, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Monica M Bertagnolli, MD, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00042770 History of Changes |
| Other Study ID Numbers: | CDR0000069451, U10CA076001, CALGB-30102 |
| Study First Received: | August 5, 2002 |
| Last Updated: | March 31, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Cancer and Leukemia Group B:
|
malignant pleural effusion pulmonary complications |
Additional relevant MeSH terms:
|
Neoplasms Neoplasm Metastasis Pleural Effusion Pleural Effusion, Malignant Neoplastic Processes Pathologic Processes |
Pleural Diseases Respiratory Tract Diseases Pleural Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on May 16, 2013