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A PHASE II STUDY OF NEOADJUVANT CHEMOTHERAPY AND RADIATION THERAPY IN THE MANAGEMENT OF HIGH-RISK, HIGH-GRADE, SOFT TISSUE SARCOMAS OF THE EXTREMITIES AND BODY WALL


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

A PHASE II STUDY OF NEOADJUVANT CHEMOTHERAPY AND RADIATION THERAPY IN THE MANAGEMENT OF HIGH-RISK, HIGH-GRADE, SOFT TISSUE SARCOMAS OF THE EXTREMITIES AND BODY WALL


OBJECTIVES: I. Assess whether patients with high-grade soft tissue sarcoma (STS) treated
with neoadjuvant mesna/doxorubicin/ifosfamide/dacarbazine (MAID) plus radiotherapy in a
cooperative group setting exhibit a response rate, toxicity, and complication rate
comparable to those seen in pilot data collected by the Massachusetts General Hospital. II.
Assess local control and local complications related to surgery and neoadjuvant MAID plus
radiotherapy in these patients. III. Develop a tissue repository of frozen STS for ancillary
genetic and flow cytometric analysis of these tumors. IV. Form an Intergroup Working Sarcoma
Group that will develop a patient base, relationships, and support for the future
development and completion of a phase III study of adjuvant therapy for STS.

OUTLINE: The following acronyms are used: DOX Doxorubicin, NSC-123127 DTIC Dacarbazine,
NSC-45388 EBRT External-Beam Radiotherapy (equipment unspecified) G-CSF Filgrastim;
Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 IFF Ifosfamide, NSC-109724 MAID
Mesna/DOX/IFF/DTIC Mesna Mercaptoethane sulfonate, NSC-113891 3-Drug Combination
Chemotherapy plus Radiotherapy followed by Surgery followed, if indicated, by Radiotherapy
followed by 3-Drug Combination Chemotherapy. MAID; plus EBRT to the primary tumor and
suspected microscopic disease; followed by minimal wide surgical excision; followed, if
positive margins, by postoperative EBRT; followed by MAID.

PROJECTED ACCRUAL: There will be 60 patients accrued into this study within 15 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed soft tissue sarcoma of an extremity or
the body wall that is a primary or a postoperatively recurrent tumor Biopsy required
within 2 months prior to entry Grade II or III tumor, including AJCC stages IIB and IIIB
lesions at least 8 cm in diameter No more than 4 chest lesions that are no greater than 3
mm in diameter on preoperative CT The following histologies are excluded: Angiosarcoma of
the scalp or face Chondrosarcoma Extraosseous Ewing's sarcoma Head and neck sarcoma
Kaposi's sarcoma Osteosarcoma Primitive neuroectodermal tumor Rhabdomyosarcoma Patients on
this study are also eligible for Frozen Tumor Repository study (protocol RTOG-9308)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80%-100%
Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 150,000/mm3 Hepatic:
Bilirubin no greater than 1.5 mg/dL SGOT no greater than 50 U Renal: Creatinine no greater
than 1.5 mg/dL Cardiovascular: No congestive heart failure (CHF) within 6 months No
myocardial infarction (MI) within 6 months No New York Heart Association class II-IV heart
disease Left ventricular ejection fraction at least 50% by MUGA or echocardiogram If
history of CHF or MI, criterion must be met within past 6 months Other: No
contraindication to surgery No uncontrolled bacterial, viral, or fungal infection No
serious medical or psychiatric illness that precludes informed consent or limits survival
to less than 2 years No second malignancy within 5 years except: Surgically treated in
situ cervical cancer Nonmelanomatous skin cancer Not pregnant or nursing Negative
pregnancy test required of fertile women within 7 days prior to entry Effective
contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No
prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy
Surgery: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

William G. Kraybill, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000064856

NCT ID:

NCT00002791

Start Date:

February 1997

Completion Date:

Related Keywords:

  • Sarcoma
  • stage II adult soft tissue sarcoma
  • stage III adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • Sarcoma

Name

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
St. Luke's Medical CenterMilwaukee, Wisconsin  53215
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
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
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
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 - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
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
CCOP - Southwestern Vermont Regional Cancer CenterBennington, Vermont  05201
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
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
Elizabeth General Medical Center - WestElizabeth, New Jersey  07201
Swedish Hospital Tumor InstituteSeattle, Washington  98104
CCOP - Ozarks RegionalSpringfield, Missouri  65807