AzTrials
AzTrials

Metastatic CancerPhase 3NCT00002622

Talc in Treating Patients With Malignant Pleural Effusion

A Phase 3 study testing talc in people with Metastatic Cancer, run by Alliance for Clinical Trials in Oncology at 241 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Metastatic Cancer
What is being tested?
talc
Could I receive a placebo?
No, everyone receives an active treatment
How many people
501 participants
Where
241 sitesin 2 countries
Study dates
Dec 1994to Jan 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

241 sites in 2 countries.

241 sites in 2 countries

United States224 sites

  • Akron General Medical Center

    Akron, Ohio, 44302

  • Akron City Hospital

    Akron, Ohio, 44309

  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • Veterans Affairs Medical Center - Albany

    Albany, New York, 12208

  • Saint Joseph Medical Center

    Albuquerque, New Mexico, 87102

  • Providence Cancer Therapy Center

    Anchorage, Alaska, 99508

  • St. John's Medical Center

    Anderson, Indiana, 46016

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan, 48105

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0752

  • Anne Arundel Oncology Center

    Annapolis, Maryland, 21401

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center and Cancer Center

    Baltimore, Maryland, 21204

  • Harbor Hospital Center

    Baltimore, Maryland, 21225

  • Radiation Oncology Affiliates of Maryland, P.A.

    Baltimore, Maryland, 21237

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21287

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Julie and Ben Rogers Cancer Institute

    Beaumont, Texas, 77701

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Veterans Affairs Medical Center - Birmingham

    Birmingham, Alabama, 35233

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Quain & Ramstad Clinic, P.C.

    Bismarck, North Dakota, 58501

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Joint Center for Radiation Therapy

    Boston, Massachusetts, 02215

  • Medical Center at Bowling Green

    Bowling Green, Kentucky, 42102

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York, 11203

  • New York Methodist Hospital

    Brooklyn, New York, 11215-3609

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • Martha Jefferson Hospital

    Charlottesville, Virginia, 22901

  • Cancer Center, University of Virginia HSC

    Charlottesville, Virginia, 22908

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • Lykes Center for Radiation Therapy

    Clearwater, Florida, 33757-0210

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210

  • Mount Diablo Medical Center

    Concord, California, 94524-4110

  • Samaritan Regional Cancer Center

    Corvallis, Oregon, 97339

  • Penn State Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Mercy Catholic Medical Center, Mercy Fitzgerald Divison

    Darby, Pennsylvania, 19023

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • Halifax Medical Center

    Daytona Beach, Florida, 32114

  • University of Colorado Cancer Center

    Denver, Colorado, 80262

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 10309-1016

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Beckman Research Institute, City of Hope

    Duarte, California, 91010

  • Wendt Regional Cancer Center of Finley Hospital

    Dubuque, Iowa, 52001

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • John F. Kennedy Medical Center

    Edison, New Jersey, 08818

  • Elizabeth General Medical Center - West

    Elizabeth, New Jersey, 07201

  • Meritcare Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Radiation Therapy Associates - Fort Myers

    Fort Myers, Florida, 33901

  • California Cancer Center

    Fresno, California, 93720

  • Saint Agnes Cancer Center

    Fresno, California, 93720

  • University of Florida Health Science Center

    Gainesville, Florida, 32610-0296

  • University of Texas Medical Branch

    Galveston, Texas, 77555-1329

  • Glendale Memorial Hospital and Health Center

    Glendale, California, 91204

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-3508

  • Sutter Health Western Division Cancer Research Group

    Greenbrae, California, 94904

  • East Carolina University School of Medicine

    Greenville, North Carolina, 27858-4354

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Penn State Geisinger Cancer Center

    Hershey, Pennsylvania, 17033

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030

  • Huntsville Hospital System

    Huntsville, Alabama, 35801

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Clarion Health Partners Inc.

    Indianapolis, Indiana, 46206-1367

  • Community Hospitals of Indianapolis - Regional Cancer Center

    Indianapolis, Indiana, 46219

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • CCOP - Dayton

    Kettering, Ohio, 45429

  • Baptist Regional Cancer Center - Knoxville

    Knoxville, Tennessee, 37901

  • Gundersen Lutheran Medical Foundation

    La Crosse, Wisconsin, 54601

  • Wilford Hall - 59th Medical Wing

    Lackland Air Force Base, Texas, 78236-5300

  • Romagosa Radiation Oncology Center

    Lafayette, Louisiana, 70501

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40511-1093

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Veterans Affairs Medical Center - Long Beach

    Long Beach, California, 90822

  • Kaiser Permanente Medical Center - Los Angeles

    Los Angeles, California, 90027

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033-0800

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Louisville Radiation Oncology

    Louisville, Kentucky, 40215

  • Virginia Baptist Hospital

    Lynchburg, Virginia, 24503

  • Veterans Affairs Medical Center - Madison

    Madison, Wisconsin, 53705

  • Southern Wisconsin Radiotherapy Center

    Madison, Wisconsin, 53713

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • Merle M. Mahr Cancer Center

    Madisonville, Kentucky, 42431

  • Elliot Regional Cancer Center

    Manchester, New Hampshire, 03103

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Marquette General Hospital

    Marquette, Michigan, 49855

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California, 94553

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Health First Holmes Regional Medical Center

    Melbourne, Florida, 32901

  • CCOP - Baptist Cancer Institute

    Memphis, Tennessee, 38117

  • University of Tennessee, Memphis Cancer Center

    Memphis, Tennessee, 38163

  • Community Memorial Hospital

    Menomonee Falls, Wisconsin, 53051

  • East Jefferson General Hospital

    Metairie, Louisiana, 70011

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • Baptist Hospital of Miami

    Miami, Florida, 33176-2197

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • South Jersey Hospital - Millville

    Millville, New Jersey, 08332

  • St. Joseph's Hospital

    Milwaukee, Wisconsin, 53210

  • Columbia Hospital

    Milwaukee, Wisconsin, 53211

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • UNI-MED Medical Center

    Minot, North Dakota, 58701

  • Urology Associates - Mobile AL

    Mobile, Alabama, 36640

  • MBCCOP - University of South Alabama

    Mobile, Alabama, 36688

  • Alabama Oncology, LLC

    Montgomery, Alabama, 36106-2801

  • Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County

    Mount Holly, New Jersey, 08060

  • Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Vanderbilt Cancer Center

    Nashville, Tennessee, 37232-6838

  • MBCCOP - LSU Medical Center

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Kaplan Cancer Center

    New York, New York, 10016

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Whittingham Cancer Center

    Norwalk, Connecticut, 06856

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • Methodist Cancer Center - Omaha

    Omaha, Nebraska, 68114

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68131

  • Florida Radiation Oncology Group

    Orange Park, Florida, 32073

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Western Baptist Hospital

    Paducah, Kentucky, 42001

  • Gulf Coast Cancer Treatment Center

    Panama City, Florida, 32405-4587

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068

  • Bayshore Medical Center

    Pasadena, Texas, 77504

  • West Florida Cancer Institute - Pensacola

    Pensacola, Florida, 32514

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Allegheny University Hospitals- Hahnemann

    Philadelphia, Pennsylvania, 19102-1192

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Veterans Affairs Medical Center - Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Champlain Valley Physicians Hospital Medical Center

    Plattsburgh, New York, 12901

  • Cancer Care Center

    Pomona, California, 91767

  • Maine Medical Center

    Portland, Maine, 04102

  • CCOP - Columbia River Program

    Portland, Oregon, 97213

  • Naval Medical Center, Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Vassar Brothers Hospital

    Poughkeepsie, New York, 12601

  • Southeastern Wisconsin Regional Cancer Center

    Racine, Wisconsin, 53405

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57709

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Mercy Medical Center - Redding

    Redding, California, 96099-6009

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Genesee Hospital - Rochester

    Rochester, New York, 14607

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • InterCommunity Cancer Center at Rome

    Rome, Georgia, 30161

  • Green Mountain Oncology Group

    Rutland, Vermont, 05701

  • Radiation Oncology Center - Sacramento

    Sacramento, California, 95816

  • St. Mary's Medical Center

    Saginaw, Michigan, 48601

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94115-0128

  • Santa Cruz Radiation Oncology Medical Group, Inc.

    Santa Cruz, California, 95065

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • CCOP - Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • Mercy Hospital Cancer Center - Scranton

    Scranton, Pennsylvania, 18501

  • Swedish Hospital Tumor Institute

    Seattle, Washington, 98104

  • Virginia Mason Medical Center

    Seattle, Washington, 98111

  • Grand View Hospital

    Sellersville, Pennsylvania, 18960

  • Siouxland Hematology-Oncology

    Sioux City, Iowa, 51101-1733

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • St. Joseph's Radiation Oncology Center

    South Bend, Indiana, 46617

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Deaconess Medical Center

    Spokane, Washington, 99210-0248

  • CCOP - Central Illinois

    Springfield, Illinois, 62526

  • Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • Veterans Affairs Medical Center - Saint Louis

    St Louis, Missouri, 63106

  • St. Louis University Health Sciences Center

    St Louis, Missouri, 63110-0250

  • Mallinckrodt Institute of Radiology

    St Louis, Missouri, 63110

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • Bayfront Medical Center

    St. Petersburg, Florida, 33701

  • Stanford University

    Stanford, California, 94305

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Albert Einstein Comprehensive Cancer Center

    The Bronx, New York, 10461

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • Community Medical Center

    Toms River, New Jersey, 08755

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • St. Francis Medical Center

    Trenton, New Jersey, 08629

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • St. John Medical Center

    Tulsa, Oklahoma, 74104

  • Radiation Oncology Associates of West Alabama

    Tuscallosa, Alabama, 35401

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • South Georgia Medical Center

    Valdosta, Georgia, 31603

  • New York Medical College

    Valhalla, New York, 10595

  • Radiation Oncology Center - Walnut Creek

    Walnut Creek, California, 94598

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • Schiffler Oncology Center

    Wheeling, West Virginia, 26003

  • Veterans Affairs Medical Center - White River Junction

    White River Junction, Vermont, 05009

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Wilkes Barre General Hospital

    Wilkes-Barre, Pennsylvania, 18764

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1082

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

  • York Hospital

    York, Pennsylvania, 17315

Other trials in United States

Canada17 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Kingston Regional Cancer Centre

    Kingston, Ontario, K7L 5P9

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Doctor Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2W-W1T8

  • Ottawa Regional Cancer Centre - Civic Campus

    Ottawa, Ontario, K1Y 4K7

  • Saskatchewan Cancer Agency

    Regina, Saskatchewan, S4S 6X3

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Northwestern Ontario Regional Cancer Centre, Thunder Bay

    Thunder Bay, Ontario, P7A 7T1

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency - Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 1J8

Other trials in Canada

About this study

Official title: Sclerosis of Pleural Effusions by Talc Thoracoscopy Versus Talc Slurry: A Phase III Study

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.

Read the 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.

Being tested
talc
Keywords
malignant pleural effusion
Medical subject headings
Neoplasm Metastasis, Pleural Effusion, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • talcDrug

    4 to 5 grams talc in 100 cc saline via chest tube at bedside, one time

  • TalcDrug

    4 to 5 grams talc via insufflation through direct or video thoracoscopy, one time

Study groups in NCT00002622
Study groupRoleWhat they receive
Talc slurry via chest tubeActive comparatortalc slurry via chest tube
Receives: Drug: talc
Talc via insufflationActive comparator4 to 5 grams talc via insufflation through direct or videoscopic thoracoscopy, one time
Receives: Drug: Talc

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful pleurodesis

    Measured: 30 days

  2. Cost and cost effectiveness

    cost and cost effectiveness of treating malignant pleural effusions

    Measured: 30 days

Secondary outcomes (2)

  1. Time to recurrence of effusion

    Measured: 6 months

  2. Complications and toxicity

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2004 (estimated)
  2. Study startDec 1994
  3. Primary completionMar 2005
  4. Study completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
501 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002622
Sponsor's protocol ID
CALGB-9334
Other IDs
U10CA031946, CLB-9334, E-C9334, NCCTG-C9334, RTOG-9511, CDR0000063982
Status last verified
Jun 2016
First submitted
1 Nov 1999
Last updated
28 Jun 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15764775

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing talc in people with Metastatic Cancer, run by Alliance for Clinical Trials in Oncology at 241 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 241 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful pleurodesis (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002622, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.

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