Talc in Treating Patients With Malignant Pleural Effusion

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Radiation Therapy Oncology Group
North Central Cancer Treatment Group
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00002622
First received: November 1, 1999
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

RATIONALE: Talc may relieve malignant pleural effusion. It is not yet known whether wet talc is more effective than dry talc in treating patients with malignant pleural effusion.

PURPOSE: Randomized phase III trial to compare the effectiveness of wet talc with dry talc in treating patients with malignant pleural effusion.


Condition Intervention Phase
Metastatic Cancer
Drug: talc
Drug: Talc
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Sclerosis of Pleural Effusions by Talc Thoracoscopy Versus Talc Slurry: A Phase III Study

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Successful pleurodesis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Cost and cost effectiveness [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    cost and cost effectiveness of treating malignant pleural effusions


Secondary Outcome Measures:
  • Time to recurrence of effusion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Complications and toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 501
Study Start Date: December 1994
Study Completion Date: January 2006
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Talc slurry via chest tube
talc slurry via chest tube
Drug: talc
4 to 5 grams talc in 100 cc saline via chest tube at bedside, one time
Active Comparator: Talc via insufflation
4 to 5 grams talc via insufflation through direct or videoscopic thoracoscopy, one time
Drug: Talc
4 to 5 grams talc via insufflation through direct or video thoracoscopy, one time

Detailed Description:

OBJECTIVES: I. Compare the proportion of patients with successful pleurodesis at 30 days following treatment for malignant pleural effusion (MPE) by talc slurry via chest tube vs thoracoscopic talc insufflation. II. Compare the cost and cost effectiveness of both treatments for MPE. III. Compare the time to recurrence of effusion, duration of chest tube drainage after sclerosis, extent of postinstillation complications and toxicities, and the ability to re-expand the lung in patients randomized to these 2 treatments. IV. Evaluate the quality of life and pain experienced by patients during both treatments.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Unilateral malignant pleural effusion requiring sclerosis (as judged by the attending surgeon) At least 3 months since treatment of contralateral effusion No chylous effusion

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002622

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States, 35233
Huntsville Hospital System
Huntsville, Alabama, United States, 35801
MBCCOP - University of South Alabama
Mobile, Alabama, United States, 36688
Urology Associates - Mobile AL
Mobile, Alabama, United States, 36640
Alabama Oncology, LLC
Montgomery, Alabama, United States, 36106-2801
Radiation Oncology Associates of West Alabama
Tuscallosa, Alabama, United States, 35401
United States, Alaska
Providence Cancer Therapy Center
Anchorage, Alaska, United States, 99508
United States, Arizona
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Mount Diablo Medical Center
Concord, California, United States, 94524-4110
Beckman Research Institute, City of Hope
Duarte, California, United States, 91010
California Cancer Center
Fresno, California, United States, 93720
Saint Agnes Cancer Center
Fresno, California, United States, 93720
Glendale Memorial Hospital and Health Center
Glendale, California, United States, 91204
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States, 90027
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
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Martinez, California, United States, 94553
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Oakland, California, United States, 94609-3305
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Pomona, California, United States, 91767
Mercy Medical Center - Redding
Redding, California, United States, 96099-6009
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Sacramento, California, United States, 95816
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San Francisco, California, United States, 94115-0128
Santa Cruz Radiation Oncology Medical Group, Inc.
Santa Cruz, California, United States, 95065
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Santa Rosa, California, United States, 95403
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Travis Air Force Base, California, United States, 94535
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Walnut Creek, California, United States, 94598
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Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
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Washington, District of Columbia, United States, 20307-5000
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Clearwater, Florida, United States, 33757-0210
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Daytona Beach, Florida, United States, 32114
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Fort Myers, Florida, United States, 33901
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Gainesville, Florida, United States, 32610-0296
Health First Holmes Regional Medical Center
Melbourne, Florida, United States, 32901
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Miami, Florida, United States, 33176-2197
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Miami, Florida, United States, 33136
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Saint Petersburg, Florida, United States, 33701
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
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Saint Louis, Missouri, United States, 63110-0250
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Saint Louis, Missouri, United States, 63110
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Saint Louis, Missouri, United States, 63106
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Springfield, Missouri, United States, 65807
United States, Montana
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Billings, Montana, United States, 59101
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Methodist Cancer Center - Omaha
Omaha, Nebraska, United States, 68114
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Omaha, Nebraska, United States, 68131
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
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Manchester, New Hampshire, United States, 03103
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East Orange, New Jersey, United States, 07018-1095
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Edison, New Jersey, United States, 08818
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Elizabeth, New Jersey, United States, 07201
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Hackensack, New Jersey, United States, 07601
South Jersey Hospital - Millville
Millville, New Jersey, United States, 08332
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
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Trenton, New Jersey, United States, 08629
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Albuquerque, New Mexico, United States, 87102
United States, New York
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Albany, New York, United States, 12208
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Albany, New York, United States, 12208
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
New York Methodist Hospital
Brooklyn, New York, United States, 11215-3609
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Kaplan Cancer Center
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States, 12901
Vassar Brothers Hospital
Poughkeepsie, New York, United States, 12601
University of Rochester Cancer Center
Rochester, New York, United States, 14642
Genesee Hospital - Rochester
Rochester, New York, United States, 14607
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
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Winston-Salem, North Carolina, United States, 27104-4241
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Winston-Salem, North Carolina, United States, 27157-1082
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Quain & Ramstad Clinic, P.C.
Bismarck, North Dakota, United States, 58501
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Minot, North Dakota, United States, 58701
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Akron City Hospital
Akron, Ohio, United States, 44309
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Akron, Ohio, United States, 44302
Christ Hospital
Cincinnati, Ohio, United States, 45219
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
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Columbus, Ohio, United States, 43206
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Dayton, Ohio, United States, 45428
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Kettering, Ohio, United States, 45429
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Toledo, Ohio, United States, 43623-3456
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St. John Medical Center
Tulsa, Oklahoma, United States, 74104
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Samaritan Regional Cancer Center
Corvallis, Oregon, United States, 97339
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Portland, Oregon, United States, 97213
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Penn State Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
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Darby, Pennsylvania, United States, 19023
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Drexel Hill, Pennsylvania, United States, 19026
Penn State Geisinger Cancer Center
Hershey, Pennsylvania, United States, 17033
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
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Philadelphia, Pennsylvania, United States, 19102-1192
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107
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Philadelphia, Pennsylvania, United States, 19104
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Philadelphia, Pennsylvania, United States, 19111
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Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
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Scranton, Pennsylvania, United States, 18501
Grand View Hospital
Sellersville, Pennsylvania, United States, 18960
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, United States, 18764
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
York Hospital
York, Pennsylvania, United States, 17315
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Tennessee
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, United States, 37901
CCOP - Baptist Cancer Institute
Memphis, Tennessee, United States, 38117
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States, 38163
Vanderbilt Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Julie and Ben Rogers Cancer Institute
Beaumont, Texas, United States, 77701
University of Texas Medical Branch
Galveston, Texas, United States, 77555-1329
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, United States, 78236-5300
Bayshore Medical Center
Pasadena, Texas, United States, 77504
United States, Utah
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
LDS Hospital
Salt Lake City, Utah, United States, 84143
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Green Mountain Oncology Group
Rutland, Vermont, United States, 05701
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States, 05009
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Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States, 22908
Martha Jefferson Hospital
Charlottesville, Virginia, United States, 22901
Virginia Baptist Hospital
Lynchburg, Virginia, United States, 24503
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
Swedish Hospital Tumor Institute
Seattle, Washington, United States, 98104
Deaconess Medical Center
Spokane, Washington, United States, 99210-0248
Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, West Virginia
Schiffler Oncology Center
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, United States, 54601
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States, 53705
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, United States, 53713
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051
St. Joseph's Hospital
Milwaukee, Wisconsin, United States, 53210
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Columbia Hospital
Milwaukee, Wisconsin, United States, 53211
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Southeastern Wisconsin Regional Cancer Center
Racine, Wisconsin, United States, 53405
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R 1J8
Canada, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Regional Cancer Centre - Civic Campus
Ottawa, Ontario, Canada, K1Y 4K7
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2W-W1T8
McGill University Department of Oncology
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Saskatchewan Cancer Agency
Regina, Saskatchewan, Canada, S4S 6X3
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Eastern Cooperative Oncology Group
Radiation Therapy Oncology Group
North Central Cancer Treatment Group
Investigators
Study Chair: Jemi Olak, MD Kern Medical Center
Study Chair: Thomas M. Daniel, MD University of Virginia
Study Chair: George B. Haasler, MD Froedtert Hospital and Medical College of Wisconsin
Study Chair: Mark S. Allen, MD Mayo Clinic
  More Information

Additional Information:
Publications:
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.

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00002622     History of Changes
Other Study ID Numbers: CDR0000063982, U10CA031946, CLB-9334, E-C9334, NCCTG-C9334, RTOG-9511
Study First Received: November 1, 1999
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
malignant pleural effusion

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
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 April 22, 2014