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Stråleterapi plus kombinationskemoterapi til behandling af patienter med småcellet lungekræft

31. oktober 2013 opdateret af: Radiation Therapy Oncology Group

Et fase I/II-eskaleringsstudie af thoraxbestråling med samtidig kemoterapi til patienter med begrænset småcellet lungekræft

RATIONALE: Lægemidler, der bruges i kemoterapi, bruger forskellige måder til at forhindre tumorceller i at dele sig, så de holder op med at vokse eller dør. Strålebehandling bruger højenergi røntgenstråler til at beskadige tumorceller. Kombination af mere end ét kemoterapilægemiddel med strålebehandling kan dræbe flere tumorceller.

FORMÅL: Fase I forsøg til undersøgelse af effektiviteten af ​​strålebehandling plus kombinationskemoterapi til behandling af patienter med småcellet lungekræft i begrænset stadie.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

MÅL: I. Bestem den maksimalt tolererede dosis af thoraxstråling ved hjælp af et accelereret boost med samtidig kemoterapi hos patienter med småcellet lungecancer. II. Evaluer responsraten og den samlede overlevelse hos disse patienter. III. Reducer de toksiske virkninger af behandling på spiserør og lunger.

OVERSIGT: Dette er en undersøgelse med eskalering af strålingsdosis. Patienter tilskrives sekventielt et af fire stråledosisniveauer. Dosisniveau 1: Patienterne modtager strålebehandling 5 dage om ugen i 4 uger efterfulgt af stråleforøgelse givet dagligt i 2 dage, derefter 2 gange dagligt i 3 dage i uge 5. (Lukket til optjening 6/98) Dosisniveau 2: Patienterne modtager strålebehandling 5 dage om ugen i 4 uger efterfulgt af strålingsboost givet 2 gange dagligt i 5 dage i uge 5. (Lukket for optjening 9/24/99) Dosisniveau 3: Patienterne modtager strålebehandling 5 dage om ugen i 18 dage efterfulgt af strålingsboost givet i aftenen på dag 19 og 20, derefter 2 gange dagligt i 5 dage i uge 5. (Lukket for optjening 5/5/00) Dosisniveau 4: Patienterne får strålebehandling 5 dage om ugen i 16 dage efterfulgt af stråleforøgelse givet om aftenen på dag 17-20, derefter to gange dagligt i 5 dage i uge 5. Det femte dosisniveau er det samme som det første dosisniveau. (Lukket for optjening 3/19/99) Kohorter på 5 patienter indtastes ved hvert stråledosisniveau. Hvis én patient oplever ikke-hæmatologisk dosisbegrænsende toksicitet (DLT), behandles yderligere 5 patienter på dette niveau. Hvis der ikke opstår yderligere DLT, fortsætter eskaleringen til næste arm. Patienterne får cisplatin IV plus etoposid IV på dag 1 af strålebehandling og oral etoposid på dag 2 og 3 hver 3. uge i 4 forløb. Patienterne følges hver 3. måned i 1 år, hver 6. måned i 2 år og derefter årligt.

PROJEKTERET TILSLUTNING: I alt 20-40 patienter vil blive akkumuleret til denne undersøgelse inden for 5-10 måneder.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

64

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center - Calgary
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
        • Newfoundland Cancer Treatment and Research Foundation
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Cancer Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Cancer Care Ontario-Hamilton Regional Cancer Centre
      • Kingston, Ontario, Canada, K7L 5P9
        • Kingston Regional Cancer Centre
      • London, Ontario, Canada, N6A 4L6
        • Cancer Care Ontario-London Regional Cancer Centre
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Regional Cancer Centre - General Campus
      • Sudbury, Ontario, Canada, P3E 5J1
        • Northeastern Ontario Regional Cancer Centre, Sudbury
      • Thunder Bay, Ontario, Canada, P7A 7T1
        • Northwestern Ontario Regional Cancer Centre, Thunder Bay
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • CHUS-Hopital Fleurimont
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University
      • Montreal, Quebec, Canada, H2L-4M1
        • Centre Hospitalier de L'Universite de Montreal
      • Quebec City, Quebec, Canada, G1R 2J6
        • CHU de Quebec - L'Hotel-Dieu de Quebec
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
      • Huntsville, Alabama, Forenede Stater, 35801
        • Comprehensive Cancer Institute of Huntsville
      • Huntsville, Alabama, Forenede Stater, 35801-4470
        • Huntsville Hospital System
      • Mobile, Alabama, Forenede Stater, 36688
        • MBCCOP - Gulf Coast
      • Montgomery, Alabama, Forenede Stater, 36106-2801
        • Alabama Oncology, LLC
      • Tuscallosa, Alabama, Forenede Stater, 35401
        • Radiation Oncology Associates of West Alabama
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85013
        • Foundation for Cancer Research and Education
      • Tucson, Arizona, Forenede Stater, 85724
        • Arizona Cancer Center
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Concord, California, Forenede Stater, 94524-4110
        • Mount Diablo Medical Center
      • Duarte, California, Forenede Stater, 91010-3000
        • Cancer Center and Beckman Research Institute, City of Hope
      • Fresno, California, Forenede Stater, 93720
        • California Cancer Center
      • Fresno, California, Forenede Stater, 93720
        • Saint Agnes Cancer Center
      • Glendale, California, Forenede Stater, 91204
        • Glendale Memorial Hospital and Health Center
      • Greenbrae, California, Forenede Stater, 94904
        • Sutter Health West Cancer Research Group
      • La Jolla, California, Forenede Stater, 92093-0658
        • University of California San Diego Cancer Center
      • Loma Linda, California, Forenede Stater, 92354
        • Loma Linda University Medical Center
      • Long Beach, California, Forenede Stater, 90822
        • Veterans Affairs Medical Center - Long Beach
      • Los Angeles, California, Forenede Stater, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, Forenede Stater, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Oakland, California, Forenede Stater, 94609-3305
        • CCOP - Bay Area Tumor Institute
      • Pasadena, California, Forenede Stater, 91105
        • Huntington Cancer Center
      • Pomona, California, Forenede Stater, 91767
        • Cancer Care Center
      • Sacramento, California, Forenede Stater, 95816
        • Radiation Oncology Center - Sacramento
      • San Diego, California, Forenede Stater, 92101-1492
        • Radiation Medical Group, Inc.
      • San Francisco, California, Forenede Stater, 94143-0128
        • UCSF Cancer Center and Cancer Research Institute
      • San Jose, California, Forenede Stater, 95128
        • O'Connor Hospital
      • Santa Rosa, California, Forenede Stater, 95403
        • CCOP - Santa Rosa Memorial Hospital
      • Travis Air Force Base, California, Forenede Stater, 94535
        • David Grant Medical Center
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80909
        • Memorial Hospital Cancer Center
      • Denver, Colorado, Forenede Stater, 80010
        • University of Colorado Cancer Center
      • Grand Junction, Colorado, Forenede Stater, 81502
        • Saint Mary's Hospital and Medical Center
    • Delaware
      • Wilmington, Delaware, Forenede Stater, 19899
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20307-5000
        • Walter Reed Army Medical Center
    • Florida
      • Clearwater, Florida, Forenede Stater, 33757-0210
        • Lykes Center for Radiation Therapy
      • Daytona Beach, Florida, Forenede Stater, 32114
        • Halifax Medical Center
      • Fort Myers, Florida, Forenede Stater, 33901
        • Radiation Therapy Associates - Fort Myers
      • Gainesville, Florida, Forenede Stater, 32610-0296
        • University of Florida Health Science Center
      • Melbourne, Florida, Forenede Stater, 32901
        • Health First Holmes Regional Medical Center
      • Miami, Florida, Forenede Stater, 33136
        • Sylvester Cancer Center, University of Miami
      • Miami, Florida, Forenede Stater, 33176-2197
        • Baptist Hospital of Miami
      • Miami, Florida, Forenede Stater, 33125
        • Veterans Affairs Medical Center - Miami
      • Miami Beach, Florida, Forenede Stater, 33140
        • CCOP - Mount Sinai Medical Center
      • Orange Park, Florida, Forenede Stater, 32073
        • Florida Radiation Oncology Group
      • Orlando, Florida, Forenede Stater, 32806
        • MD Anderson Cancer Center Orlando
      • Panama City, Florida, Forenede Stater, 32405-4587
        • Gulf Coast Cancer Treatment Center
      • Panama City, Florida, Forenede Stater, 32401
        • Bay Medical Center
      • Sarasota, Florida, Forenede Stater, 34233
        • Sarasota Radiation and Medical Oncology Center
      • Tallahassee, Florida, Forenede Stater, 32308
        • Tallahassee Memorial HealthCare
      • Tampa, Florida, Forenede Stater, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University Hospital - Atlanta
      • Atlanta, Georgia, Forenede Stater, 30342-1701
        • CCOP - Atlanta Regional
      • Columbus, Georgia, Forenede Stater, 31902
        • Medical Center/John B. Amos Community Cancer Center
      • Rome, Georgia, Forenede Stater, 30165
        • InterCommunity Cancer Center at Rome
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Arlington Heights, Illinois, Forenede Stater, 60005
        • Northwest Community Hospital
      • Chicago, Illinois, Forenede Stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern Memorial Hospital
      • Decatur, Illinois, Forenede Stater, 62526
        • CCOP - Central Illinois
      • Elgin, Illinois, Forenede Stater, 60123
        • Provena St. Joseph Hospital- Regional Cancer Care Center
      • Harvey, Illinois, Forenede Stater, 60426
        • Ingalls Memorial Hospital
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Medical Center
      • Park Ridge, Illinois, Forenede Stater, 60068
        • Lutheran General Cancer Care Center
      • Peoria, Illinois, Forenede Stater, 61636
        • Methodist Medical Center of Illinois
    • Indiana
      • Anderson, Indiana, Forenede Stater, 46016
        • St. John's Medical Center
      • Bloomington, Indiana, Forenede Stater, 47402
        • Bloomington Hospital
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Veterans Affairs Medical Center - Indianapolis (Roudebush)
      • Indianapolis, Indiana, Forenede Stater, 46206-1367
        • Clarion Health Partners Inc.
      • Indianapolis, Indiana, Forenede Stater, 46219
        • Community Hospitals of Indianapolis - Regional Cancer Center
      • Muncie, Indiana, Forenede Stater, 47303-3499
        • Ball Memorial Hospital
      • South Bend, Indiana, Forenede Stater, 46601
        • CCOP - Northern Indiana CR Consortium
    • Iowa
      • Dubuque, Iowa, Forenede Stater, 52001
        • Wendt Regional Cancer Center of Finley Hospital
      • Iowa City, Iowa, Forenede Stater, 52242-1009
        • Holden Comprehensive Cancer Center at the University of Iowa
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40511-1093
        • Veterans Affairs Medical Center - Lexington
      • Lexington, Kentucky, Forenede Stater, 40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky
      • Lexington, Kentucky, Forenede Stater, 40503
        • Central Baptist Hospital
      • Louisville, Kentucky, Forenede Stater, 40202
        • James Graham Brown Cancer Center
      • Louisville, Kentucky, Forenede Stater, 40215
        • Louisville Radiation Oncology
      • Madisonville, Kentucky, Forenede Stater, 42431
        • Merle M. Mahr Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Mary Bird Perkins Cancer Center
      • Lafayette, Louisiana, Forenede Stater, 70501
        • Romagosa Radiation Oncology Center
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, Forenede Stater, 70121
        • CCOP - Ochsner
      • New Orleans, Louisiana, Forenede Stater, 70112
        • MBCCOP - LSU Health Sciences Center
    • Maine
      • Portland, Maine, Forenede Stater, 04102
        • Maine Medical Center
    • Maryland
      • Annapolis, Maryland, Forenede Stater, 21401
        • Anne Arundel Oncology Center
      • Baltimore, Maryland, Forenede Stater, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Baltimore, Maryland, Forenede Stater, 21225
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, Forenede Stater, 21204
        • Greater Baltimore Medical Center and Cancer Center
      • Baltimore, Maryland, Forenede Stater, 21225
        • Harbor Hospital Center
      • Baltimore, Maryland, Forenede Stater, 21237
        • Radiation Oncology Affiliates of Maryland, P.A.
      • Salisbury, Maryland, Forenede Stater, 21801
        • Peninsula Regional Medical Center
    • Massachusetts
      • Hyannis, Massachusetts, Forenede Stater, 02601
        • Cape Cod Hospital
      • Jamaica Plain, Massachusetts, Forenede Stater, 02130
        • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-0752
        • University of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • CCOP - Ann Arbor Regional
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Forenede Stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
      • Flint, Michigan, Forenede Stater, 48432
        • McLaren Regional Cancer Center
      • Kalamazoo, Michigan, Forenede Stater, 49007-3731
        • CCOP - Kalamazoo
      • Marquette, Michigan, Forenede Stater, 49855
        • Marquette General Hospital
      • Midland, Michigan, Forenede Stater, 48670
        • MidMichigan Medical Center - Midland
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital
      • Saginaw, Michigan, Forenede Stater, 48601
        • St. Mary's Medical Center
      • Troy, Michigan, Forenede Stater, 48098
        • William Beaumont Hospital - Troy
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic Cancer Center
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • CCOP - Metro-Minnesota
    • Mississippi
      • Tupelo, Mississippi, Forenede Stater, 38801
        • North Mississippi Medical Center/Cancer Center
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65203
        • Ellis Fischel Cancer Center - Columbia
      • Kansas City, Missouri, Forenede Stater, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Forenede Stater, 63110-0250
        • St. Louis University Health Sciences Center
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Mallinckrodt Institute of Radiology
      • Springfield, Missouri, Forenede Stater, 65807
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, Forenede Stater, 65807
        • Cancer Research for the Ozarks
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • CCOP - Montana Cancer Consortium
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68114
        • Methodist Cancer Center - Omaha
      • Omaha, Nebraska, Forenede Stater, 68105-1018
        • Nebraska Health System
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756-0002
        • Norris Cotton Cancer Center
      • Manchester, New Hampshire, Forenede Stater, 03103
        • Elliot Regional Cancer Center
    • New Jersey
      • East Orange, New Jersey, Forenede Stater, 07018-1095
        • Veterans Affairs Medical Center - East Orange
      • Edison, New Jersey, Forenede Stater, 08818
        • John F. Kennedy Medical Center
      • Elizabeth, New Jersey, Forenede Stater, 07201
        • Trinitas Hospital - Jersey Street Campus
      • Long Branch, New Jersey, Forenede Stater, 07740-6395
        • Monmouth Medical Center
      • Millville, New Jersey, Forenede Stater, 08332
        • South Jersey Regional Cancer Center
      • Mount Holly, New Jersey, Forenede Stater, 08060
        • Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Cancer Institute Of New Jersey
      • Newark, New Jersey, Forenede Stater, 07112
        • Newark Beth Israel Medical Center
      • Pomona, New Jersey, Forenede Stater, 08240
        • Atlantic City Medical Center
      • Ridgewood, New Jersey, Forenede Stater, 07450
        • Valley Hospital
      • Toms River, New Jersey, Forenede Stater, 08755
        • Community Medical Center
      • Trenton, New Jersey, Forenede Stater, 08629
        • St. Francis Medical Center
      • Warren, New Jersey, Forenede Stater, 07059
        • Associated Radiologists, P.A.
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87102
        • Saint Joseph Medical Center
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Cancer Center of Albany Medical Center
      • Bronx, New York, Forenede Stater, 10461
        • Albert Einstein Comprehensive Cancer Center
      • Brooklyn, New York, Forenede Stater, 11203
        • State University of New York Health Science Center at Brooklyn
      • Brooklyn, New York, Forenede Stater, 11215-3609
        • New York Methodist Hospital
      • Buffalo, New York, Forenede Stater, 14263-0001
        • Roswell Park Cancer Institute
      • Clifton Springs, New York, Forenede Stater, 14432
        • Finger Lakes Radiation Oncology, P.C.
      • Manhasset, New York, Forenede Stater, 11030
        • CCOP - North Shore University Hospital
      • New York, New York, Forenede Stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Forenede Stater, 10003
        • Beth Israel Medical Center
      • New York, New York, Forenede Stater, 10032
        • Herbert Irving Comprehensive Cancer Center
      • Plattsburgh, New York, Forenede Stater, 12901
        • Champlain Valley Physicians Hospital Medical Center
      • Poughkeepsie, New York, Forenede Stater, 12601
        • Vassar Brothers Hospital
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester Cancer Center
      • Syracuse, New York, Forenede Stater, 13217
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
      • Valhalla, New York, Forenede Stater, 10595
        • New York Medical College
      • Yonkers, New York, Forenede Stater, 10701
        • Riverhill Radiation Oncology
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
      • Concord, North Carolina, Forenede Stater, 28025
        • Northeast Medical Center
      • Greenville, North Carolina, Forenede Stater, 27858-4354
        • East Carolina University School of Medicine
      • Hickory, North Carolina, Forenede Stater, 28601
        • Catawba Memorial Hospital
      • Winston-Salem, North Carolina, Forenede Stater, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58122
        • Meritcare Roger Maris Cancer Center
      • Minot, North Dakota, Forenede Stater, 58701
        • Trinity Cancer Care Center
    • Ohio
      • Akron, Ohio, Forenede Stater, 44302
        • Akron General Medical Center
      • Akron, Ohio, Forenede Stater, 44309
        • Akron City Hospital
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Barrett Cancer Center, The University Hospital
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Christ Hospital
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Forenede Stater, 44106
        • University Hospitals of Cleveland
      • Cleveland, Ohio, Forenede Stater, 44106-5065
        • Ireland Cancer Center
      • Columbus, Ohio, Forenede Stater, 43210-1240
        • Arthur G. James Cancer Hospital - Ohio State University
      • Columbus, Ohio, Forenede Stater, 43206
        • CCOP - Columbus
      • Kettering, Ohio, Forenede Stater, 45429
        • CCOP - Dayton
      • Toledo, Ohio, Forenede Stater, 43623-3456
        • CCOP - Toledo Community Hospital Oncology Program
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma University Medical center
      • Oklahoma City, Oklahoma, Forenede Stater, 73101
        • St. Anthony Hospital
      • Tulsa, Oklahoma, Forenede Stater, 74104
        • St. John Health System
    • Oregon
      • Portland, Oregon, Forenede Stater, 97213
        • CCOP - Columbia River Program
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Lehigh Valley Hospital
      • Bethlehem, Pennsylvania, Forenede Stater, 18015
        • St. Luke's Hospital Regional Cancer Center
      • Danville, Pennsylvania, Forenede Stater, 17822-2001
        • Geisinger Medical Center
      • Darby, Pennsylvania, Forenede Stater, 19023
        • Fitzgerald Mercy Hospital
      • Drexel Hill, Pennsylvania, Forenede Stater, 19026
        • Delaware County Memorial Hospital
      • East Stroudsburg, Pennsylvania, Forenede Stater, 18301
        • Pocono Cancer Center
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Penn State Geisinger Cancer Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Veterans Affairs Medical Center - Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 19141
        • Albert Einstein Cancer Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19102-1192
        • Hahnemann University Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19104-4283
        • University of Pennsylvania Cancer Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
        • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • Western Pennsylvania Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213-3489
        • University of Pittsburgh Cancer Institute
      • Pittsburgh, Pennsylvania, Forenede Stater, 15219
        • Mercy Hospital of Pittsburgh
      • Reading, Pennsylvania, Forenede Stater, 19612-6052
        • Reading Hospital and Medical Center
      • Scranton, Pennsylvania, Forenede Stater, 18501
        • Mercy Hospital Cancer Center - Scranton
      • Sellersville, Pennsylvania, Forenede Stater, 18960
        • Grand View Hospital
      • Wilkes-Barre, Pennsylvania, Forenede Stater, 18764
        • Wilkes Barre General Hospital
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • CCOP - MainLine Health
      • York, Pennsylvania, Forenede Stater, 17315
        • York Hospital
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02908-4735
        • Roger Williams Medical Center/BUSM
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425-0721
        • Medical University of South Carolina
      • Greenville, South Carolina, Forenede Stater, 29615
        • CCOP - Greenville
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • CCOP - Upstate Carolina
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57709
        • Rapid City Regional Hospital
    • Tennessee
      • Jackson, Tennessee, Forenede Stater, 38301
        • Jackson-Madison County General Hospital
      • Memphis, Tennessee, Forenede Stater, 38103
        • University of Tennessee, Memphis Cancer Center
      • Nashville, Tennessee, Forenede Stater, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Harrington Cancer Center
      • Beaumont, Texas, Forenede Stater, 77701
        • Julie and Ben Rogers Cancer Institute
      • Galveston, Texas, Forenede Stater, 77555-0209
        • University of Texas Medical Branch
      • Houston, Texas, Forenede Stater, 77030-4009
        • University of Texas - MD Anderson Cancer Center
      • Lackland Air Force Base, Texas, Forenede Stater, 78236-5300
        • Wilford Hall - 59th Medical Wing
      • Lubbock, Texas, Forenede Stater, 79410-1894
        • Joe Arrington Cancer Research and Treatment Center
      • Pasadena, Texas, Forenede Stater, 77504
        • Bayshore Medical Center
      • Tyler, Texas, Forenede Stater, 75701
        • East Texas Medical Center - Cancer Institute
    • Utah
      • Saint George, Utah, Forenede Stater, 84770
        • Dixie Regional Medical Center
      • Salt Lake City, Utah, Forenede Stater, 84132
        • University of Utah Health Sciences Center
      • Salt Lake City, Utah, Forenede Stater, 84143
        • LDS Hospital
    • Vermont
      • Bennington, Vermont, Forenede Stater, 05201
        • CCOP - Southwestern Vermont Regional Cancer Center
      • Burlington, Vermont, Forenede Stater, 05401-3498
        • Vermont Cancer Center
      • Rutland, Vermont, Forenede Stater, 05701
        • Green Mountain Oncology Group
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22901
        • Martha Jefferson Hospital
      • Charlottesville, Virginia, Forenede Stater, 22908
        • Cancer Center at the University of Virginia
      • Harrisonburg, Virginia, Forenede Stater, 22801
        • RMH Regional Canter Center
      • Portsmouth, Virginia, Forenede Stater, 23708-2197
        • Naval Medical Center, Portsmouth
      • Richmond, Virginia, Forenede Stater, 23298-0037
        • Massey Cancer Center
      • Richmond, Virginia, Forenede Stater, 23226
        • Bon-Secours - St. Mary's Hospital
    • Washington
      • Seattle, Washington, Forenede Stater, 98111
        • Virginia Mason Medical Center
      • Spokane, Washington, Forenede Stater, 99210-0248
        • Deaconess Medical Center
      • Yakima, Washington, Forenede Stater, 98902
        • Yakima Valley Memorial Hospital
    • West Virginia
      • Wheeling, West Virginia, Forenede Stater, 26003
        • Schiffler Cancer Center
    • Wisconsin
      • Green Bay, Wisconsin, Forenede Stater, 54307-3508
        • St. Vincent Hospital
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Medical Foundation
      • Madison, Wisconsin, Forenede Stater, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center
      • Madison, Wisconsin, Forenede Stater, 53713
        • Southern Wisconsin Radiotherapy Center
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Clinic
      • Menomonee Falls, Wisconsin, Forenede Stater, 53051
        • Community Memorial Hospital
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53210
        • St. Joseph's Hospital
      • Milwaukee, Wisconsin, Forenede Stater, 53211
        • Columbia Hospital
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • St. Luke's Medical Center
      • Milwaukee, Wisconsin, Forenede Stater, 53295
        • Veterans Affairs Medical Center - Milwaukee (Zablocki)
      • Racine, Wisconsin, Forenede Stater, 53405
        • Southeastern Wisconsin Regional Cancer Center
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • Waukesha Memorial Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

SYGDOMSKARAKTERISTIKA: Histologisk eller cytologisk bekræftet småcellet karcinom i lungen Begrænset sygdom (stadium I-IIIb, men ekskl. T4-tumor baseret på malign pleuraeffusion eller N3-sygdom baseret på kontralateral hilar eller kontralateral supraclavikulær involvering) Ingen perikardie- eller pleuraeffusion på brystet x- stråle uanset cytologi Målbar eller evaluerbar sygdom Tumor skal være omfattet af begrænsede stråleterapifelter uden at forårsage alvorlig symptomatisk lungedysfunktion

PATIENTKARAKTERISTIKA: Alder: 18 til 80 Ydeevnestatus: Karnofsky 70-100 % Forventet levetid: Større end 6 måneder Hæmatopoietisk: Absolut granulocyttal mindst 1.500/mm3 Trombocyttal mindst 150.000/mm3 Lever: større end 1 biliru. Nyre: Kreatinin ikke større end 1,5 mg/dL Kardiovaskulær: Ingen symptomatisk hjertesygdom Mindst 6 måneder siden tidligere myokardieinfarkt Lunge: Se Sygdomskarakteristika Forceret ekspiratorisk volumen på et sekund (FEV1) større end 0,8 L Ingen ukontrolleret bronkospasme i upåvirket lunge Andet: Ingen anden alvorlig samtidig sygdom Ingen tidligere eller samtidig malignitet inden for de seneste 2 år undtagen kurativt behandlet basalcelle- eller pladecellehudkræft eller carcinom in situ i livmoderhalsen Ingen anden samtidig malignitet Ingen historie med ukontrolleret psykiatrisk sygdom, alvorlig hovedskade, kronisk alkohol eller stofmisbrug eller sygdom i centralnervesystemet Fertile patienter skal bruge effektiv prævention

TIDLIGERE SAMTYDLIG BEHANDLING: Biologisk behandling: Ikke specificeret Kemoterapi: Ingen forudgående kemoterapi Endokrin behandling: Ikke specificeret Strålebehandling: Ingen forudgående strålebehandling Kirurgi: Ingen forudgående fuldstændig tumorresektion

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 1
Storfelt strålebehandling 36 Gy, 1,8 Gy/fx/D/5 dage/4 uger, boost 1,8 Gy/D x 2 dage, derefter BID x sidste 3 dage.
Stråling: strålebehandling
Medicin: etoposid
Medicin: cisplatin
Eksperimentel: Arm 2
Storfelt strålebehandling 36 Gy, 1,8 Gy/fx/D/5 dage/4 uger, boost 1,8 Gy/BID x sidste 5 dage.
Stråling: strålebehandling
Medicin: etoposid
Medicin: cisplatin
Eksperimentel: Arm 3
Strålebehandling i stort felt 32,4 Gy, 1,8 Gy/fx/D/5 dage x 18 fx, boost lige om kl.
Stråling: strålebehandling
Medicin: etoposid
Medicin: cisplatin
Eksperimentel: Arm 4
Strålebehandling i stort felt 28,8 Gy, 1,8 Gy/fx/5 dage x 16 fx, boost lige om kl. @ 1,8 Gy/fx på dag 17-20, derefter boost 1,8 Gy BID x sidste 5 dage.
Stråling: strålebehandling
Medicin: etoposid
Medicin: cisplatin
Eksperimentel: Arm 5
Storfelt strålebehandling 36 Gy, 1,8 Gy/fx/D 5 dage/4 uger, boost 1,8 Gy/D x 2 dage, derefter BID x sidste 3 dage.
Stråling: strålebehandling
Medicin: etoposid
Medicin: cisplatin
Eksperimentel: Arm 6
Strålebehandling i stort felt 25,2 Gy, 1,8 Gy/fx/5 dage x 14 fx, boost lige om kl. @ 1,8 Gy/fx på dagene 15-20, derefter boost 1,8 Gy BID x sidste 5 dage.
Stråling: strålebehandling
Medicin: etoposid
Medicin: cisplatin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Hyppighed af patienter, der udvikler uacceptabel (grad 3 eller højere) akut toksicitet, der kan tilskrives thoraxbestråling med samtidig kemoterapi
Tidsramme: Fra behandlingsstart til 90 dage
Fra behandlingsstart til 90 dage

Sekundære resultatmål

Resultatmål
Tidsramme
Sammenlign baseline og opfølgende Mini Mental Status Undersøgelser
Tidsramme: Fra baseline til slutningen af ​​opfølgningen
Fra baseline til slutningen af ​​opfølgningen

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Radiation Therapy Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 1998

Primær færdiggørelse (Faktiske)

1. oktober 2002

Studieafslutning (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først indsendt

6. april 2000

Først indsendt, der opfyldte QC-kriterier

28. januar 2004

Først opslået (Skøn)

29. januar 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. november 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. oktober 2013

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RTOG-9712
  • CDR0000065797

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lungekræft

Kliniske forsøg med strålebehandling

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Rwanda

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner