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Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer Clinical research trials and Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer. Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer  Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer
Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer
For Condition: Pulmonary Complications,Malignant Pleural Effusion
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: 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 malignantpleural effusion. PURPOSE: Randomizedphase 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ToddDemmy, Study Chair, Roswell Park Cancer Institute
Saint Anthony Medical Center *Recruiting*
Rockford, Illinois, 61108
United States
Recruiting Richard Nora 815-227-2273
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Clara Bloomfield 614-293-7518
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Stephen Graziano 315-464-8200
University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester, Massachusetts, 01655
United States
Recruiting Pankaj Bhargava 508-856-6884
Lifespan: The Miriam Hospital *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting William Sikov 401-793-7151
Lenoir Memorial Hospital Cancer Center *Recruiting*
Kinston, North Carolina, 28503-1678
United States
Recruiting Peter Watson 919-559-2200 Ext. 201
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7295
United States
Recruiting Thomas Shea 919-966-7746
University of Puerto Rico School of Medicine Medical Sciences Campus *Recruiting*
San Juan, , 00936-5067
Puerto Rico
Recruiting Enrique Velez-Garcia 787-754-0101 Ext.2020
Veterans Affairs Medical Center - Dallas *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Barry Levinson 214-648-4193
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
Florida Hospital Cancer Institute *Recruiting*
Orlando, Florida, 32804
United States
Recruiting Jane Crofton 407-303-2090
Roswell Park Cancer Institute *Recruiting*
Buffalo, New York, 14263-0001
United States
Recruiting Ellis Levine 716-845-8547
Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis, Minnesota, 55417
United States
Recruiting Vicki Morrison 612-725-2000 ext. 4135
CCOP - North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Daniel Budman 516-562-8915
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
Veterans Affairs Medical Center - Washington, DC *Recruiting*
Washington D.C., District of Columbia, 20422
United States
Recruiting Steven Krasnow 202-745-8178
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Martin Edelman 410-328-2703
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting George Canellos 617-632-3470
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Scott Wadler 212-746-2844
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Debasish Tripathy 214-648-5113
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Elmhurst Hospital Center *Recruiting*
Elmhurst, New York, 11373
United States
Recruiting Vladimir Benisovich 718-334-3723
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Karen Wendling 773-834-7424
Veterans Affairs Medical Center - Columbia (Truman Memorial) *Recruiting*
Columbia, Missouri, 65201
United States
Recruiting William Patterson 573-882-6163
Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Thomas Lad 312-996-2046
Veterans Affairs Medical Center - San Francisco *Recruiting*
San Francisco, California, 94121
United States
Recruiting Patricia Cornett 415-221-4810 ext. 3423
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Jeffrey Crawford 919-684-5195
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Veterans Affairs Medical Center - Syracuse *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Stephen Graziano 315-476-7461
West Suburban Center for Cancer Care *Recruiting*
River Forest, Illinois, 60305
United States
Recruiting John Showel 708-763-2700
New Hanover Regional Medical Center *Recruiting*
Wilmington, North Carolina, 28402-9025
United States
Recruiting Cyrus Kotwall 910-763-4630
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Michael Perry 573-882-4979
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1009
United States
Recruiting Gerald Clamon 319-356-1932
Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Edward Gelmann 202-444-7303
Barnes-Jewish Hospital *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Nancy Bartlett 314-747-3000
Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood, Florida, 33021
United States
Recruiting Atif Hussein 954-986-6363
Cape Fear Valley Health System *Recruiting*
Fayetteville, North Carolina, 28302-2000
United States
Recruiting Kamal Bakri 910-609-6910
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Alan Venook 800-888-8664
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John Roberts 804-828-0450
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Alan Lefor 310-423-5874
Louis A. Weiss Memorial Hospital *Recruiting*
Chicago, Illinois, 60640
United States
Recruiting Keith Shulman 773-564-5022
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103
United States
Recruiting Edison Catalano 856-342-2506
Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica, New York, 11432
United States
Recruiting Hans Grunwald 718-883-4118
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Lewis Silverman 212-241-5520
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett, New Hampshire, 03106
United States
Recruiting Douglas Weckstein 603-622-6484
Oncology and Hematology Associates of Southwest Virginia, Inc. *Recruiting*
Roanoke, Virginia, 24014
United States
Recruiting Paul Richards 540-982-0237
Martha Jefferson Hospital *Recruiting*
Charlottesville, Virginia, 22902
United States
Recruiting Stefan Gorsch 434-982-8410
Northeast Alabama Regional Medical Center *Recruiting*
Anniston, Alabama, 36207
United States
Recruiting Thomas Twele 256-236-2549
Veterans Affairs Medical Center - Las Vegas *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting Chitha Hulugalle 702-696-3000
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Clifford Hudis 212-639-6483
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
Veterans Affairs Medical Center - San Diego *Recruiting*
San Diego, California, 92161
United States
Recruiting Saeeda Kirmani 619-552-8585 ext. 3356
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Bruce Peterson 612-624-5631
NorthEast Oncology Associates *Recruiting*
Concord, North Carolina, 28025
United States
Recruiting James Wall 704-783-1370
Walter Reed Army Medical Center *Recruiting*
Washington D.C., District of Columbia, 20307-5000
United States
Recruiting Joseph Drabick 202-782-6751
Baptist Hospital East - Louisville *Recruiting*
Louisville, Kentucky, 40207
United States
Recruiting Daniel Scullin 502-897-1166
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
Missouri Baptist Cancer Center *Recruiting*
St. Louis, Missouri, 63131
United States
Recruiting Alan Lyss 314-996-5514
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse, New York, 13217
United States
Recruiting Jeffrey Kirshner 315-472-7504
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-982-4963
St. Mary's Medical Center *Recruiting*
Huntington, West Virginia, 25701
United States
Recruiting Gerrit Kimmey 304-528-4645
FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst, North Carolina, 28374
United States
Recruiting Ellen Willard 910-295-9205
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Daniel Budman 516-562-8958
Veterans Affairs Medical Center - Durham *Recruiting*
Durham, North Carolina, 27705
United States
Recruiting Michael Kelley 919-286-0411
Vermont Cancer Center at University of Vermont *Recruiting*
Burlington, Vermont, 05401-3498
United States
Recruiting Hyman Muss 802-847-3827
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Margaret Kessinger 402-559-7511
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
Veterans Affairs Medical Center - Asheville *Recruiting*
Asheville, North Carolina, 28805
United States
Recruiting John Lucke 828-299-2540
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting Sreenivasa Nattam 219-484-8830
Green Mountain Oncology Group *Recruiting*
Bennington, Vermont, 05201
United States
Recruiting L. Maurer 802-442-1290
CCOP - Mount Sinai Medical Center *Recruiting*
Miami, Florida, 33140
United States
Recruiting Rogerio Lilenbaum 305-674-2625
Veterans Affairs Medical Center - Buffalo *Recruiting*
Buffalo, New York, 14215
United States
Recruiting Lynn Steinbrenner 716-862-3191
Veterans Affairs Medical Center - White River Junction *Recruiting*
White River Junction, Vermont, 05009
United States
Recruiting Joseph O'Donnell 802-295-9363 ext. 5480
Broward General Medical Center *Recruiting*
Ft. Lauderdale, Florida, 33316
United States
Recruiting Luis Barreras 954-771-0692
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Marc Ernstoff 603-650-5534
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting David Hurd 336-716-2088
Virginia Oncology Associates - Norfolk *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Paul Conkling 757-466-8683
Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla, California, 92093-0658
United States
Recruiting Stephen Seagren 858-657-7020
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting Richard Shadduck 412-578-4355
Palm Beach Cancer Institute *Recruiting*
West Palm Beach, Florida, 33401
United States
Recruiting Robert Jacobson 561-366-4150
Additional Information:
Study ID Numbers: CDR0000069451; CALGB-30102
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042770
Other Malignant Pleural Effusion Studies:
1. Study of Lung Function in Children Who Have Undergone Bone Marrow Transplantation
2. Buspirone in Reducing Shortness of Breath in Patients With Cancer
3. Captopril in Treating Patients With Non-Small Cell Lung Cancer or Limited-Stage Small Cell Lung Cancer That Has Been Previously Treated With Radiation Therapy With or Without Chemotherapy
4. Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Disease
5. Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Related Studies:
Other Malignant Pleural Effusion Clinical Trials
Other Alabama Clinical Trials
Other Anniston Clinical Trials
Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer
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