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


Phase 3
18 Years
N/A
Not Enrolling
Both
Metastatic Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Successful pleurodesis

Outcome Time Frame:

30 days

Safety Issue:

No

Principal Investigator

Jemi Olak, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kern Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000063982

NCT ID:

NCT00002622

Start Date:

December 1994

Completion Date:

January 2006

Related Keywords:

  • Metastatic Cancer
  • malignant pleural effusion
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Pleural Effusion
  • Pleural Effusion, Malignant

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Location

Akron City HospitalAkron, Ohio  44304
Arizona Cancer CenterTucson, Arizona  85724
Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Kaplan Cancer CenterNew York, New York  10016
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
University of Colorado Cancer CenterDenver, Colorado  80262
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
University of Rochester Cancer CenterRochester, New York  14642
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
St. Luke's Medical CenterMilwaukee, Wisconsin  53215
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
Hurley Medical CenterFlint, Michigan  48503
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Baptist Regional Cancer Center - KnoxvilleKnoxville, Tennessee  37901
CCOP - DuluthDuluth, Minnesota  55805
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Loyola University Medical CenterMaywood, Illinois  60153
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Quain & Ramstad Clinic, P.C.Bismarck, North Dakota  58501
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
Henry Ford HospitalDetroit, Michigan  48202
Marshfield ClinicMarshfield, Wisconsin  54449
Medical College of WisconsinMilwaukee, Wisconsin  53226
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
Huntsville Hospital SystemHuntsville, Alabama  35801
MBCCOP - University of South AlabamaMobile, Alabama  36688
Urology Associates - Mobile ALMobile, Alabama  36640
Alabama Oncology, LLCMontgomery, Alabama  36106-2801
Radiation Oncology Associates of West AlabamaTuscallosa, Alabama  35401
Providence Cancer Therapy CenterAnchorage, Alaska  99508
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
Mount Diablo Medical CenterConcord, California  94524-4110
California Cancer CenterFresno, California  93720
Saint Agnes Cancer CenterFresno, California  93720
Glendale Memorial Hospital and Health CenterGlendale, California  91204
Sutter Health Western Division Cancer Research GroupGreenbrae, California  94904
Loma Linda University Medical CenterLoma Linda, California  92354
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Kaiser Permanente Medical Center - Los AngelesLos Angeles, California  90027
Beckman Research Institute, City of HopeLos Angeles, California  91010
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Cancer Care CenterPomona, California  91767
Mercy Medical Center - ReddingRedding, California  96099-6009
Radiation Oncology Center - SacramentoSacramento, California  95816
Santa Cruz Radiation Oncology Medical Group, Inc.Santa Cruz, California  95065
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
Stanford UniversityStanford, California  94305
David Grant Medical CenterTravis Air Force Base, California  94535
Radiation Oncology Center - Walnut CreekWalnut Creek, California  94598
Memorial Hospital Cancer CenterColorado Springs, Colorado  80909
Bridgeport HospitalBridgeport, Connecticut  06610
Whittingham Cancer CenterNorwalk, Connecticut  06856
Lykes Center for Radiation TherapyClearwater, Florida  33757-0210
Halifax Medical CenterDaytona Beach, Florida  32114
Radiation Therapy Associates - Fort MyersFort Myers, Florida  33901
University of Florida Health Science CenterGainesville, Florida  32610-0296
Health First Holmes Regional Medical CenterMelbourne, Florida  32901
Baptist Hospital of MiamiMiami, Florida  33176-2197
Florida Radiation Oncology GroupOrange Park, Florida  32073
Gulf Coast Cancer Treatment CenterPanama City, Florida  32405-4587
West Florida Cancer Institute - PensacolaPensacola, Florida  32514
Bayfront Medical CenterSaint Petersburg, Florida  33701
InterCommunity Cancer Center at RomeRome, Georgia  30161
South Georgia Medical CenterValdosta, Georgia  31603
Northwestern Memorial HospitalChicago, Illinois  60611
Ingalls Memorial HospitalHarvey, Illinois  60426
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Central IllinoisSpringfield, Illinois  62526
St. John's Medical CenterAnderson, Indiana  46016
Clarion Health Partners Inc.Indianapolis, Indiana  46206-1367
Community Hospitals of Indianapolis - Regional Cancer CenterIndianapolis, Indiana  46219
Ball Memorial HospitalMuncie, Indiana  47303-3499
Memorial Hospital of South BendSouth Bend, Indiana  46601
St. Joseph's Radiation Oncology CenterSouth Bend, Indiana  46617
Wendt Regional Cancer Center of Finley HospitalDubuque, Iowa  52001
Medical Center at Bowling GreenBowling Green, Kentucky  42102
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Louisville Radiation OncologyLouisville, Kentucky  40215
Merle M. Mahr Cancer CenterMadisonville, Kentucky  42431
Western Baptist HospitalPaducah, Kentucky  42001
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Romagosa Radiation Oncology CenterLafayette, Louisiana  70501
East Jefferson General HospitalMetairie, Louisiana  70011
Maine Medical CenterPortland, Maine  04102
Anne Arundel Oncology CenterAnnapolis, Maryland  21401
Greater Baltimore Medical Center and Cancer CenterBaltimore, Maryland  21204
Harbor Hospital CenterBaltimore, Maryland  21225
Radiation Oncology Affiliates of Maryland, P.A.Baltimore, Maryland  21237
Joint Center for Radiation TherapyBoston, Massachusetts  02215
Cape Cod HospitalHyannis, Massachusetts  02601
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
Marquette General HospitalMarquette, Michigan  49855
St. Mary's Medical CenterSaginaw, Michigan  48601
Veterans Affairs Medical Center - Saint LouisSaint Louis, Missouri  63106
Mallinckrodt Institute of RadiologySaint Louis, Missouri  63110
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Methodist Cancer Center - OmahaOmaha, Nebraska  68114
Elliot Regional Cancer CenterManchester, New Hampshire  03103
John F. Kennedy Medical CenterEdison, New Jersey  08818
South Jersey Hospital - MillvilleMillville, New Jersey  08332
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington CountyMount Holly, New Jersey  08060
Community Medical CenterToms River, New Jersey  08755
St. Francis Medical CenterTrenton, New Jersey  08629
Saint Joseph Medical CenterAlbuquerque, New Mexico  87102
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
New York Methodist HospitalBrooklyn, New York  11215-3609
Champlain Valley Physicians Hospital Medical CenterPlattsburgh, New York  12901
Vassar Brothers HospitalPoughkeepsie, New York  12601
Genesee Hospital - RochesterRochester, New York  14607
New York Medical CollegeValhalla, New York  10595
Meritcare Roger Maris Cancer CenterFargo, North Dakota  58122
UNI-MED Medical CenterMinot, North Dakota  58701
Akron General Medical CenterAkron, Ohio  44302
Christ HospitalCincinnati, Ohio  45219
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
St. John Medical CenterTulsa, Oklahoma  74104
Samaritan Regional Cancer CenterCorvallis, Oregon  97339
CCOP - Columbia River ProgramPortland, Oregon  97213
Penn State Geisinger Medical CenterDanville, Pennsylvania  17822-2001
Mercy Catholic Medical Center, Mercy Fitzgerald DivisonDarby, Pennsylvania  19023
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Penn State Geisinger Cancer CenterHershey, Pennsylvania  17033
Allegheny University Hospitals- HahnemannPhiladelphia, Pennsylvania  19102-1192
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Veterans Affairs Medical Center - PhiladelphiaPhiladelphia, Pennsylvania  19104
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Mercy Hospital Cancer Center - ScrantonScranton, Pennsylvania  18501
Grand View HospitalSellersville, Pennsylvania  18960
Wilkes Barre General HospitalWilkes-Barre, Pennsylvania  18764
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
York HospitalYork, Pennsylvania  17315
CCOP - GreenvilleGreenville, South Carolina  29615
Jackson-Madison County General HospitalJackson, Tennessee  38301
Julie and Ben Rogers Cancer InstituteBeaumont, Texas  77701
University of Texas Medical BranchGalveston, Texas  77555-1329
Wilford Hall - 59th Medical WingLackland Air Force Base, Texas  78236-5300
Bayshore Medical CenterPasadena, Texas  77504
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
Green Mountain Oncology GroupRutland, Vermont  05701
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Martha Jefferson HospitalCharlottesville, Virginia  22901
Virginia Baptist HospitalLynchburg, Virginia  24503
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer CenterRichmond, Virginia  23298-0037
Virginia Mason Medical CenterSeattle, Washington  98111
Deaconess Medical CenterSpokane, Washington  99210-0248
Yakima Valley Memorial HospitalYakima, Washington  98902
Schiffler Oncology CenterWheeling, West Virginia  26003
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
Gundersen Lutheran Medical FoundationLa Crosse, Wisconsin  54601
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Southern Wisconsin Radiotherapy CenterMadison, Wisconsin  53713
Community Memorial HospitalMenomonee Falls, Wisconsin  53051
Columbia HospitalMilwaukee, Wisconsin  53211
St. Joseph's HospitalMilwaukee, Wisconsin  53210
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
Southeastern Wisconsin Regional Cancer CenterRacine, Wisconsin  53405
Elizabeth General Medical Center - WestElizabeth, New Jersey  07201
Swedish Hospital Tumor InstituteSeattle, Washington  98104