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Phase 2
18 Years
Not Enrolling

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Trial Information


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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

William G. Kraybill, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Federal Government

Study ID:




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



Akron City Hospital Akron, Ohio  44304
Arizona Cancer Center Tucson, Arizona  85724
Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Kaplan Cancer Center New York, New York  10016
Mayo Clinic Cancer Center Rochester, Minnesota  55905
University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
University of Colorado Cancer Center Denver, Colorado  80262
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Johns Hopkins Oncology Center Baltimore, Maryland  21287
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
University of Rochester Cancer Center Rochester, New York  14642
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
St. Luke's Medical Center Milwaukee, Wisconsin  53215
Sylvester Cancer Center, University of Miami Miami, Florida  33136
MBCCOP - LSU Medical Center New Orleans, Louisiana  70112
Hurley Medical Center Flint, Michigan  48503
East Carolina University School of Medicine Greenville, North Carolina  27858-4354
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Baptist Cancer Institute Memphis, Tennessee  38117
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
CCOP - Carle Cancer Center Urbana, Illinois  61801
New England Medical Center Hospital Boston, Massachusetts  02111
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Baptist Regional Cancer Center - Knoxville Knoxville, Tennessee  37901
CCOP - Duluth Duluth, Minnesota  55805
Vanderbilt Cancer Center Nashville, Tennessee  37232-6838
MD Anderson Cancer Center Orlando Orlando, Florida  32806
Loyola University Medical Center Maywood, Illinois  60153
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
CCOP - Ochsner New Orleans, Louisiana  70121
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
Henry Ford Hospital Detroit, Michigan  48202
Marshfield Clinic Marshfield, Wisconsin  54449
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Veterans Affairs Medical Center - Birmingham Birmingham, Alabama  35233
Huntsville Hospital System Huntsville, Alabama  35801
MBCCOP - University of South Alabama Mobile, Alabama  36688
Urology Associates - Mobile AL Mobile, Alabama  36640
Alabama Oncology, LLC Montgomery, Alabama  36106-2801
Radiation Oncology Associates of West Alabama Tuscallosa, Alabama  35401
Providence Cancer Therapy Center Anchorage, Alaska  99508
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
Mount Diablo Medical Center Concord, California  94524-4110
California Cancer Center Fresno, California  93720
Saint Agnes Cancer Center Fresno, California  93720
Glendale Memorial Hospital and Health Center Glendale, California  91204
Sutter Health Western Division Cancer Research Group Greenbrae, California  94904
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
Beckman Research Institute, City of Hope Los Angeles, California  91010
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
Cancer Care Center Pomona, California  91767
Mercy Medical Center - Redding Redding, California  96099-6009
Radiation Oncology Center - Sacramento Sacramento, California  95816
Santa Cruz Radiation Oncology Medical Group, Inc. Santa Cruz, California  95065
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
Stanford University Stanford, California  94305
David Grant Medical Center Travis Air Force Base, California  94535
Radiation Oncology Center - Walnut Creek Walnut Creek, California  94598
Memorial Hospital Cancer Center Colorado Springs, Colorado  80909
Bridgeport Hospital Bridgeport, Connecticut  06610
Whittingham Cancer Center Norwalk, Connecticut  06856
Lykes Center for Radiation Therapy Clearwater, Florida  33757-0210
Halifax Medical Center Daytona Beach, Florida  32114
Radiation Therapy Associates - Fort Myers Fort Myers, Florida  33901
University of Florida Health Science Center Gainesville, Florida  32610-0296
Health First Holmes Regional Medical Center Melbourne, Florida  32901
Baptist Hospital of Miami Miami, Florida  33176-2197
Florida Radiation Oncology Group Orange Park, Florida  32073
Gulf Coast Cancer Treatment Center Panama City, Florida  32405-4587
West Florida Cancer Institute - Pensacola Pensacola, Florida  32514
Bayfront Medical Center Saint Petersburg, Florida  33701
InterCommunity Cancer Center at Rome Rome, Georgia  30161
South Georgia Medical Center Valdosta, Georgia  31603
Northwestern Memorial Hospital Chicago, Illinois  60611
Ingalls Memorial Hospital Harvey, Illinois  60426
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
Methodist Medical Center of Illinois Peoria, Illinois  61636
CCOP - Central Illinois Springfield, Illinois  62526
St. John's Medical Center Anderson, Indiana  46016
Clarion Health Partners Inc. Indianapolis, Indiana  46206-1367
Community Hospitals of Indianapolis - Regional Cancer Center Indianapolis, Indiana  46219
Ball Memorial Hospital Muncie, Indiana  47303-3499
Memorial Hospital of South Bend South Bend, Indiana  46601
St. Joseph's Radiation Oncology Center South Bend, Indiana  46617
Wendt Regional Cancer Center of Finley Hospital Dubuque, Iowa  52001
Medical Center at Bowling Green Bowling Green, Kentucky  42102
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
James Graham Brown Cancer Center Louisville, Kentucky  40202
Louisville Radiation Oncology Louisville, Kentucky  40215
Merle M. Mahr Cancer Center Madisonville, Kentucky  42431
Western Baptist Hospital Paducah, Kentucky  42001
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
Romagosa Radiation Oncology Center Lafayette, Louisiana  70501
East Jefferson General Hospital Metairie, Louisiana  70011
Maine Medical Center Portland, Maine  04102
Anne Arundel Oncology Center Annapolis, Maryland  21401
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
Joint Center for Radiation Therapy Boston, Massachusetts  02215
Cape Cod Hospital Hyannis, Massachusetts  02601
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
Marquette General Hospital Marquette, Michigan  49855
St. Mary's Medical Center Saginaw, Michigan  48601
Veterans Affairs Medical Center - Saint Louis Saint Louis, Missouri  63106
Mallinckrodt Institute of Radiology Saint Louis, Missouri  63110
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
Methodist Cancer Center - Omaha Omaha, Nebraska  68114
Elliot Regional Cancer Center Manchester, New Hampshire  03103
John F. Kennedy Medical Center Edison, New Jersey  08818
South Jersey Hospital - Millville Millville, New Jersey  08332
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County Mount Holly, New Jersey  08060
Community Medical Center Toms River, New Jersey  08755
St. Francis Medical Center Trenton, New Jersey  08629
Saint Joseph Medical Center Albuquerque, New Mexico  87102
Veterans Affairs Medical Center - Albany Albany, New York  12208
New York Methodist Hospital Brooklyn, New York  11215-3609
Champlain Valley Physicians Hospital Medical Center Plattsburgh, New York  12901
Vassar Brothers Hospital Poughkeepsie, New York  12601
Genesee Hospital - Rochester Rochester, New York  14607
New York Medical College Valhalla, New York  10595
Meritcare Roger Maris Cancer Center Fargo, North Dakota  58122
UNI-MED Medical Center Minot, North Dakota  58701
Akron General Medical Center Akron, Ohio  44302
Christ Hospital Cincinnati, Ohio  45219
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
St. John Medical Center Tulsa, Oklahoma  74104
Samaritan Regional Cancer Center Corvallis, Oregon  97339
CCOP - Columbia River Program Portland, Oregon  97213
Penn State Geisinger Medical Center Danville, Pennsylvania  17822-2001
Mercy Catholic Medical Center, Mercy Fitzgerald Divison Darby, Pennsylvania  19023
Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
Penn State Geisinger Cancer Center Hershey, Pennsylvania  17033
Allegheny University Hospitals- Hahnemann Philadelphia, Pennsylvania  19102-1192
Albert Einstein Cancer Center Philadelphia, Pennsylvania  19141
Veterans Affairs Medical Center - Philadelphia Philadelphia, Pennsylvania  19104
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Mercy Hospital Cancer Center - Scranton Scranton, Pennsylvania  18501
Grand View Hospital Sellersville, Pennsylvania  18960
Wilkes Barre General Hospital Wilkes-Barre, Pennsylvania  18764
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
York Hospital York, Pennsylvania  17315
CCOP - Greenville Greenville, South Carolina  29615
Jackson-Madison County General Hospital Jackson, Tennessee  38301
Julie and Ben Rogers Cancer Institute Beaumont, Texas  77701
University of Texas Medical Branch Galveston, Texas  77555-1329
Wilford Hall - 59th Medical Wing Lackland Air Force Base, Texas  78236-5300
Bayshore Medical Center Pasadena, Texas  77504
Dixie Regional Medical Center Saint George, Utah  84770
LDS Hospital Salt Lake City, Utah  84143
CCOP - Southwestern Vermont Regional Cancer Center Bennington, Vermont  05201
Green Mountain Oncology Group Rutland, Vermont  05701
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Martha Jefferson Hospital Charlottesville, Virginia  22901
Virginia Baptist Hospital Lynchburg, Virginia  24503
Naval Medical Center, Portsmouth Portsmouth, Virginia  23708-2197
Massey Cancer Center Richmond, Virginia  23298-0037
Virginia Mason Medical Center Seattle, Washington  98111
Deaconess Medical Center Spokane, Washington  99210-0248
Yakima Valley Memorial Hospital Yakima, Washington  98902
Schiffler Oncology Center Wheeling, West Virginia  26003
St. Vincent Hospital Green Bay, Wisconsin  54307-3508
Gundersen Lutheran Medical Foundation La Crosse, Wisconsin  54601
Veterans Affairs Medical Center - Madison Madison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Southern Wisconsin Radiotherapy Center Madison, Wisconsin  53713
Community Memorial Hospital Menomonee Falls, Wisconsin  53051
Columbia Hospital Milwaukee, Wisconsin  53211
St. Joseph's Hospital Milwaukee, Wisconsin  53210
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
Southeastern Wisconsin Regional Cancer Center Racine, Wisconsin  53405
CCOP - Marshfield Medical Research and Education Foundation Marshfield, Wisconsin  54449
Elizabeth General Medical Center - West Elizabeth, New Jersey  07201
Swedish Hospital Tumor Institute Seattle, Washington  98104
CCOP - Ozarks Regional Springfield, Missouri  65807