Talc in Treating Patients With Malignant Pleural Effusion
NCT ID: NCT00002622
Last Updated: 2016-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
501 participants
INTERVENTIONAL
1994-12-31
2006-01-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of wet talc with dry talc in treating patients with malignant pleural effusion.
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Detailed Description
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OUTLINE: This is a randomized study. Patients are stratified according to participating institution. Patients are randomized to one of two treatment arms. Arm I: Patients undergo pleurodesis. A chest tube is inserted, the pleural fluid is drained for 24 hours, and the lung is re-expanded to at least 90% of full expansion. Within 24-36 hours patients undergo sclerosis with talc slurry injected into the chest tube, which is then clamped. Patients are rotated in all possible directions, holding each position for about 30 minutes. After 2 hours the chest tube is unclamped and reattached to suction drainage, which is strictly measured for 24-hour totals. Following a decrease in drainage to no more than 150 ml/24 hours (usually by the second or third day postsclerosis), the chest tube is removed. Arm II: Patients receive thoracoscopic insufflation. The chest is explored thoracoscopically via single or multiple incisions using direct or videothoracoscopic visualization, and the lung is re-expanded to 90% of full expansion. Dry talc is pneumatically insufflated into the chest, with complete dispersion throughout the hemithorax. Following insufflation, the chest is drained via a chest tube, which is removed when the drainage is no more than 150 ml/24 hours (usually by day 2 or 3 following insufflation). Patients are removed from study for disease progression or an unsuccessful lung re-expansion. Patients are followed monthly for 6 months for relapse and survival.
PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study over 28 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Talc slurry via chest tube
talc slurry via chest tube
talc
4 to 5 grams talc in 100 cc saline via chest tube at bedside, one time
Talc via insufflation
4 to 5 grams talc via insufflation through direct or videoscopic thoracoscopy, one time
Talc
4 to 5 grams talc via insufflation through direct or video thoracoscopy, one time
Interventions
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talc
4 to 5 grams talc in 100 cc saline via chest tube at bedside, one time
Talc
4 to 5 grams talc via insufflation through direct or video thoracoscopy, one time
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Able to undergo thoracoscopy under general or local anesthesia (as determined by the attending surgeon) Not pregnant Tests and observations must be completed within 1 week prior to randomization (chest x-ray within 1 week prior to procedure)
PRIOR CONCURRENT THERAPY: No prior intrapleural therapy No systemic therapy within 2 weeks prior to randomization or 2 weeks post pleurodesis Biologic therapy: Not specified Chemotherapy: No new systemic chemotherapy for 2 weeks prior to and at least 2 weeks after pleurodesis Endocrine therapy: No new hormonal therapy for 2 weeks prior to and at least 2 weeks after pleurodesis No concurrent steroids used as antiemetics Radiotherapy: Prior radiotherapy allowed No radiotherapy to entire hemithorax Palliative irradiation of symptomatic bone lesions allowed on the affected side if field does not include a significant portion of pleura Surgery: See Disease Characteristics
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Radiation Therapy Oncology Group
NETWORK
North Central Cancer Treatment Group
NETWORK
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Jemi Olak, MD
Role: STUDY_CHAIR
Kern Medical Center
Locations
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Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
Huntsville Hospital System
Huntsville, Alabama, United States
Urology Associates - Mobile AL
Mobile, Alabama, United States
MBCCOP - University of South Alabama
Mobile, Alabama, United States
Alabama Oncology, LLC
Montgomery, Alabama, United States
Radiation Oncology Associates of West Alabama
Tuscallosa, Alabama, United States
Providence Cancer Therapy Center
Anchorage, Alaska, United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
Mount Diablo Medical Center
Concord, California, United States
Beckman Research Institute, City of Hope
Duarte, California, United States
California Cancer Center
Fresno, California, United States
Saint Agnes Cancer Center
Fresno, California, United States
Glendale Memorial Hospital and Health Center
Glendale, California, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Cancer Care Center
Pomona, California, United States
Mercy Medical Center - Redding
Redding, California, United States
Radiation Oncology Center - Sacramento
Sacramento, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Santa Cruz Radiation Oncology Medical Group, Inc.
Santa Cruz, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Stanford University
Stanford, California, United States
David Grant Medical Center
Travis Air Force Base, California, United States
Radiation Oncology Center - Walnut Creek
Walnut Creek, California, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Whittingham Cancer Center
Norwalk, Connecticut, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Lykes Center for Radiation Therapy
Clearwater, Florida, United States
Halifax Medical Center
Daytona Beach, Florida, United States
Radiation Therapy Associates - Fort Myers
Fort Myers, Florida, United States
University of Florida Health Science Center
Gainesville, Florida, United States
Health First Holmes Regional Medical Center
Melbourne, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Radiation Oncology Group
Orange Park, Florida, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States
West Florida Cancer Institute - Pensacola
Pensacola, Florida, United States
Bayfront Medical Center
St. Petersburg, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
InterCommunity Cancer Center at Rome
Rome, Georgia, United States
South Georgia Medical Center
Valdosta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
CCOP - Central Illinois
Springfield, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
St. John's Medical Center
Anderson, Indiana, United States
Clarion Health Partners Inc.
Indianapolis, Indiana, United States
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, United States
Ball Memorial Hospital
Muncie, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
St. Joseph's Radiation Oncology Center
South Bend, Indiana, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
Medical Center at Bowling Green
Bowling Green, Kentucky, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Louisville Radiation Oncology
Louisville, Kentucky, United States
Merle M. Mahr Cancer Center
Madisonville, Kentucky, United States
Western Baptist Hospital
Paducah, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Romagosa Radiation Oncology Center
Lafayette, Louisiana, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
Anne Arundel Oncology Center
Annapolis, Maryland, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States
Harbor Hospital Center
Baltimore, Maryland, United States
Radiation Oncology Affiliates of Maryland, P.A.
Baltimore, Maryland, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Joint Center for Radiation Therapy
Boston, Massachusetts, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Marquette General Hospital
Marquette, Michigan, United States
St. Mary's Medical Center
Saginaw, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Cancer Research for the Ozarks
Springfield, Missouri, United States
Veterans Affairs Medical Center - Saint Louis
St Louis, Missouri, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
Mallinckrodt Institute of Radiology
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Methodist Cancer Center - Omaha
Omaha, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Elliot Regional Cancer Center
Manchester, New Hampshire, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
John F. Kennedy Medical Center
Edison, New Jersey, United States
Elizabeth General Medical Center - West
Elizabeth, New Jersey, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
South Jersey Hospital - Millville
Millville, New Jersey, United States
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
Mount Holly, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
St. Francis Medical Center
Trenton, New Jersey, United States
Saint Joseph Medical Center
Albuquerque, New Mexico, United States
Cancer Center of Albany Medical Center
Albany, New York, United States
Veterans Affairs Medical Center - Albany
Albany, New York, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States
New York Methodist Hospital
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
Kaplan Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States
Vassar Brothers Hospital
Poughkeepsie, New York, United States
Genesee Hospital - Rochester
Rochester, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Quain & Ramstad Clinic, P.C.
Bismarck, North Dakota, United States
Meritcare Roger Maris Cancer Center
Fargo, North Dakota, United States
UNI-MED Medical Center
Minot, North Dakota, United States
Akron General Medical Center
Akron, Ohio, United States
Akron City Hospital
Akron, Ohio, United States
Christ Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Kettering, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
St. John Medical Center
Tulsa, Oklahoma, United States
Samaritan Regional Cancer Center
Corvallis, Oregon, United States
CCOP - Columbia River Program
Portland, Oregon, United States
Penn State Geisinger Medical Center
Danville, Pennsylvania, United States
Mercy Catholic Medical Center, Mercy Fitzgerald Divison
Darby, Pennsylvania, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Penn State Geisinger Cancer Center
Hershey, Pennsylvania, United States
Allegheny University Hospitals- Hahnemann
Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States
Grand View Hospital
Sellersville, Pennsylvania, United States
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, United States
CCOP - Baptist Cancer Institute
Memphis, Tennessee, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States
Vanderbilt Cancer Center
Nashville, Tennessee, United States
Julie and Ben Rogers Cancer Institute
Beaumont, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, United States
Bayshore Medical Center
Pasadena, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center
St. George, Utah, United States
Green Mountain Oncology Group
Rutland, Vermont, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States
Martha Jefferson Hospital
Charlottesville, Virginia, United States
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States
Virginia Baptist Hospital
Lynchburg, Virginia, United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States
Massey Cancer Center
Richmond, Virginia, United States
Swedish Hospital Tumor Institute
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Deaconess Medical Center
Spokane, Washington, United States
Yakima Valley Memorial Hospital
Yakima, Washington, United States
Schiffler Oncology Center
Wheeling, West Virginia, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States
St. Joseph's Hospital
Milwaukee, Wisconsin, United States
Columbia Hospital
Milwaukee, Wisconsin, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States
Southeastern Wisconsin Regional Cancer Center
Racine, Wisconsin, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Ottawa Regional Cancer Centre - Civic Campus
Ottawa, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
McGill University Department of Oncology
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Saskatchewan Cancer Agency
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Countries
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References
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Dresler CM, Olak J, Herndon JE 2nd, Richards WG, Scalzetti E, Fleishman SB, Kernstine KH, Demmy T, Jablons DM, Kohman L, Daniel TM, Haasler GB, Sugarbaker DJ; Cooperative Groups Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; North Central Cooperative Oncology Group; Radiation Therapy Oncology Group. Phase III intergroup study of talc poudrage vs talc slurry sclerosis for malignant pleural effusion. Chest. 2005 Mar;127(3):909-15. doi: 10.1378/chest.127.3.909.
Fleishman SB, Dresler C, Herndon JE, et al.: Quality of life (QOL) advantage of sclerosis for malignant pleural effusion (MPE) via talc thoracoscopy over chest tube infusion of talc slurry: a cancer and leukemia group B study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1418, 2002.
Dresler CM, Herndon JE, Daniels T, et al.: Cancer and Leukemia Group B (CALGB) 9334: a phase III, intergroup study of sclerosis of malignant pleural effusion by talc. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A2455, 2000.
Other Identifiers
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CLB-9334
Identifier Type: -
Identifier Source: secondary_id
E-C9334
Identifier Type: -
Identifier Source: secondary_id
NCCTG-C9334
Identifier Type: -
Identifier Source: secondary_id
RTOG-9511
Identifier Type: -
Identifier Source: secondary_id
CDR0000063982
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-9334
Identifier Type: -
Identifier Source: org_study_id
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