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Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: June 28, 2006   Last Updated: November 25, 2009   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00346164
  Purpose

RATIONALE: Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known which regimen is more effective in treating soft tissue sarcoma.

PURPOSE: This phase III trial is studying observation to see how well it works compared with radiation therapy, combination chemotherapy, and/or surgery in treating patients with soft tissue sarcoma.


Condition Intervention Phase
Childhood Malignant Fibrous Histiocytoma of Bone
Sarcoma
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Procedure: observation
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Risk-Based Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS) in Patients Under 30 Years of Age

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Long-term survival at 5 years [ Designated as safety issue: No ]
  • Event-free and overall survival at 5 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local tumor control at 5 years [ Designated as safety issue: No ]
  • Feasibility of neoadjuvant chemoradiotherapy [ Designated as safety issue: No ]
  • Imaging and pathologic response after neoadjuvant chemoradiotherapy, and their relationship to survival and local outcomes [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: February 2007
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1: Experimental
(Low risk [nonmetastatic, grossly resected disease, except high-grade tumor > 5 cm]): Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to receive regimen A (observation only). Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to receive regimen B (beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy).
Procedure: observation
Patients undergo observation
Radiation: radiation therapy
Patients undergo radiotherapy
Group 2: Experimental
(Intermediate risk [nonmetastatic, resected high-grade tumor > 5 cm or unresected disease]): Patients with grossly resected, high-grade tumor > 5 cm (in maximum diameter) are assigned to receive regimen C (adjuvant chemoradiotherapy) for approximately 19 weeks. Patients with unresected tumor are assigned to receive regimen D (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy) lasting approximately 25 weeks.
Drug: doxorubicin hydrochloride
Given IV
Drug: ifosfamide
Given IV
Procedure: therapeutic conventional surgery
Patients undergo surgery
Radiation: radiation therapy
Patients undergo radiotherapy
Group 3: Experimental
(High risk [metastatic, resected, incompletely resected, or unresected disease]): Patients with low-grade, all-sites resected tumor with either negative or positive microscopic margins are assigned to receive treatment as in group 1 regimen A. Patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive treatment as in group 2 regimen C. Patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in group 2 regimen D.
Drug: doxorubicin hydrochloride
Given IV
Drug: ifosfamide
Given IV
Procedure: observation
Patients undergo observation
Procedure: therapeutic conventional surgery
Patients undergo surgery
Radiation: radiation therapy
Patients undergo radiotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma (STS), confirmed by central pathology review via concurrent enrollment on protocol COG-D9902

    • Metastatic or nonmetastatic disease
  • Meets 1 of the following criteria:

    • Intermediate (i.e., rarely metastasizing) or malignant STS, including any of the following:

      • Adipocytic tumor, including liposarcoma of any of the following histology subtypes:

        • Dedifferentiated
        • Myxoid
        • Round cell
        • Pleomorphic type
        • Mixed-type
        • Not otherwise specified (NOS)
      • Fibroblastic/myofibroblastic tumors, including any of the following:

        • Solitary fibrous tumor
        • Hemangiopericytoma
        • Low-grade myofibroblastic sarcoma
        • Myxoinflammatory fibroblastic sarcoma
        • Adult fibrosarcoma* NOTE: *Patients < 2 years of age with infantile fibrosarcoma not allowed
        • Myxofibrosarcoma
        • Low-grade fibromyxoid sarcoma or hyalinizing spindle cell tumor
        • Sclerosing epithelioid fibrosarcoma
      • So-called fibrohistiocytic tumors, including any of the following:

        • Plexiform fibrohistiocytic tumor
        • Giant cell tumor of soft tissues
        • Pleomorphic malignant fibrous histiocytoma (MFH)/undifferentiated pleomorphic sarcoma
        • Giant cell MFH/undifferentiated pleomorphic sarcoma with giant cells
        • Inflammatory MFH/undifferentiated pleomorphic sarcoma with prominent inflammation
      • Smooth muscle tumor (leiomyosarcoma)
      • Pericytic [perivascular] tumor (malignant glomus tumor or glomangiosarcoma)
      • Vascular tumor, including angiosarcoma
      • Chondro-osseous tumors of any of the following types:

        • Mesenchymal chondrosarcoma
        • Extraskeletal osteosarcoma
      • Tumors of uncertain differentiation, including any of the following:

        • Angiomatoid fibrous histiocytoma
        • Ossifying fibromyxoid tumor
        • Myoepithelioma/parachordoma
        • Synovial sarcoma
        • Epithelioid sarcoma
        • Alveolar soft-part sarcoma
        • Clear cell sarcoma of soft tissue
        • Extraskeletal myxoid chondrosarcoma ("chordoid type")
        • Malignant mesenchymoma
        • Neoplasms with perivascular epithelioid cell differentiation (PEComa)
        • Clear cell myomelanocytic tumor
        • Intimal sarcoma
    • Malignant peripheral nerve sheath tumor
    • Dermatofibrosarcoma protuberans meeting both of the following criteria:

      • Nonmetastatic disease
      • Tumor must be grossly resected prior to study enrollment
    • Embryonal sarcoma of the liver
    • Unclassified STS that is too undifferentiated to be placed in a specific pathologic category (undifferentiated STS or STS NOS)
  • Gross resection of the primary tumor ≤ 42 days prior to enrollment required except if any of the following circumstances apply:

    • Nonmetastatic high-grade tumor > 5 cm in maximal diameter and gross or microscopic residual tumor is anticipated after resection
    • Tumor of either high- or- low-grade that cannot be grossly excised without unacceptable morbidity
    • High-grade tumor with metastases

      • Patients with metastatic low-grade tumor whose disease is amenable to gross resection at all sites must undergo gross resection of all sites prior to study entry
  • Patients with a tumor recurrence after a gross total resection are not eligible
  • Patients with epithelioid sarcoma, clear cell sarcoma, or clinical or radiologic evidence of regional lymph node enlargement must undergo sentinel lymph node biopsies or lymph node sampling to confirm the status of regional lymph nodes*

    • If lymph node biopsies are positive for tumor (or the lymph nodes are classified as positive by the study radiologist), formal lymph node dissection must be done at the time of definitive surgery (prior to study entry for patients assigned to study regimen C)
  • NOTE: *Except in cases where the study radiologist reviews the imaging and indicates that a biopsy is not needed to confirm that the patient has lymph node involvement.
  • Patients with metastatic disease must undergo a biopsy to confirm the presence of metastatic tumor if all metastases are < 1 cm in maximal diameter (except in cases where the study radiologist reviews the imaging and indicated that a biopsy is not needed to confirm that the patient has metastatic disease)

PATIENT CHARACTERISTICS:

  • Lansky performance status (PS) 50-100% (for patients ≤ 16 years of age) OR Karnofsky PS 50-100% (for patients > 16 years of age)
  • Life expectancy ≥ 3 months
  • Hemoglobin ≥ 10 g/dL (may be supported by transfusion)*
  • Absolute neutrophil count ≥ 1,000/mm³*
  • Platelet count ≥ 100,000/mm³*
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min (≥ 40 mL/min for infants < 1 year of age)*
  • Patients with urinary tract obstruction by tumor must meet the renal function criteria listed above AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)*
  • Shortening fraction ≥ 27% by echocardiogram* OR ejection fraction ≥ 50% by radionuclide angiogram*
  • Not pregnant or nursing

    • No nursing for ≥ 1 month after completion of study treatment in study regimens C or D
  • Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
  • No evidence of dyspnea at rest*
  • No exercise intolerance*
  • Resting pulse oximetry reading > 94% on room air (for patients with respiratory symptoms)* NOTE: *Patients eligible for study regimen A (observation only) are not required to meet the organ function requirements; patients eligible for study regimen B are required to have adequate organ function in the organs that are within the radiotherapy field; patients eligible for study regimens C or D must meet all organ function requirements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior treatment for cancer allowed provided the patient meet the prior therapy requirements
  • No prior anthracycline (e.g., doxorubicin ir daunorubicin) or ifosfamide chemotherapy for patients enrolled on arm C or arm D
  • No prior radiotherapy to tumor-involved sites
  • No concurrent aprepitant during chemotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346164

  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - UAB Comprehensive Cancer Center     205-934-0309        
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center Recruiting
Tucson, Arizona, United States, 85724-5024
Contact: Clinical Trials Office - Arizona Cancer Center at University o     520-626-9008        
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016-7710
Contact: Jessica L. Boklan     602-546-0920        
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni     501-686-8274        
United States, California
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Recruiting
Long Beach, California, United States, 90801
Contact: Jerry Z. Finklestein     562-492-1062        
Children's Hospital Central California Recruiting
Madera, California, United States, 93638-8762
Contact: Vonda L. Crouse     559-353-5480        
Childrens Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas     323-361-2529        
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Violet Shen     714-532-8636        
Children's Hospital and Research Center Oakland Recruiting
Oakland, California, United States, 94609
Contact: Clinical Trial Office - Children's Hospital and Research Cente     510-450-7600        
Jonsson Comprehensive Cancer Center at UCLA Recruiting
Los Angeles, California, United States, 90095-1781
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a     888-798-0719        
Kaiser Permanente Medical Center - Oakland Recruiting
Sacramento, California, United States, 95825
Contact: Vincent Kiley     916-474-2326        
Loma Linda University Cancer Institute at Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Clinical Trials Office - Loma Linda University Cancer Institut     909-558-3375        
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123-4282
Contact: Clinical Trials Office - Rady Children's Hospital - San Diego     858-966-5934        
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048-1865
Contact: Carole H. Hurvitz     310-423-4423        
Southern California Permanente Medical Group Recruiting
Downey, California, United States, 90027
Contact: Robert M. Cooper     323-783-5307        
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305-5824
Contact: Clinical Trials Office - Stanford Cancer Center     650-498-7061     cctoffice@stanford.edu    
Sutter Cancer Center Recruiting
Sacramento, California, United States, 95816
Contact: Clinical Trial Office - Sutter Cancer Center     916-454-6595        
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi     877-827-3222        
United States, Colorado
Children's Hospital Center for Cancer and Blood Disorders Recruiting
Aurora, Colorado, United States, 80045
Contact: Kelly Maloney     720-777-6673        
Presbyterian - St. Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Clinical Trials Office - Presbyterian - St. Luke's Medical Cen     303-839-6000        
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06360-2875
Contact: Clinical Trials Office - Carole and Ray Neag Comprehensive Can     800-579-7822        
United States, Delaware
Alfred I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Clinical Trials Office - Alfred I. duPont Hospital for Childre     302-651-5755        
United States, District of Columbia
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307-5001
Contact: Clinical Trials Office - Walter Reed Army Medical Center     202-782-7840        
United States, Florida
All Children's Hospital Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Gregory Hale     727-767-4176        
M.D. Anderson Cancer Center at Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Vincent F. Giusti     321-841-8588        
Florida Hospital Cancer Institute at Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute     407-303-5623        
Kaplan Cancer Center at St. Mary's Medical Center Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Narayana Gowda     561-844-6363        
Lee Cancer Care of Lee Memorial Health System Recruiting
Fort Myers, Florida, United States, 33901
Contact: Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt     877-680-0008        
Baptist-South Miami Regional Cancer Program Recruiting
Miami, Florida, United States, 33176
Contact: Doured Daghistani     305-274-1662        
Memorial Cancer Institute at Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Clinical Trials Office - Memorial Cancer Institute     954-985-3443        
Miami Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Enrique Escalon     305-662-8360x4960        
Nemours Children's Clinic - Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Paul R. Gordon     407-650-7330        
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Eric S. Sandler     904-697-3793        
Sacred Heart Cancer Center at Sacred Heart Hospital Recruiting
Pensacola, Florida, United States, 32504
Contact: Clinical Trials Office - Sacred Heart Cancer Center     850-416-4611        
St. Joseph's Cancer Institute at St. Joseph's Hospital Recruiting
Tampa, Florida, United States, 33607
Contact: Clinical Trials Office - St. Joseph's Cancer Institute     800-882-4123        
University of Miami Sylvester Comprehensive Cancer Center - Miami Recruiting
Miami, Florida, United States, 33136
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin     866-574-5124     Sylvester@emergingmed.com    
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Howard M. Katzenstein     404-785-0853        
United States, Hawaii
Cancer Research Center of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Clinical Trials Office - Cancer Research Center of Hawaii     808-586-2979        
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center Recruiting
Boise, Idaho, United States, 83712-6297
Contact: Eugenia Chang     208-381-2731        
United States, Illinois
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Sharad Salvi     708-684-4094        
Advocate Lutheran General Cancer Care Center Recruiting
Park Ridge, Illinois, United States, 60068-1174
Contact: Clinical Trials Office - Advocate Lutheran General Cancer Care     847-384-3621        
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center     708-226-4357        
Children's Memorial Hospital - Chicago Recruiting
Chicago, Illinois, United States, 60614
Contact: Stewart Goldman     773-880-3270        
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Stephen D. Smith     309-624-4945        
Simmons Cooper Cancer Institute Recruiting
Springfield, Illinois, United States, 62794-9677
Contact: Clinical Trials Office - Simmons Cooper Cancer Institute     217-545-7929        
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612-7243
Contact: Clinical Trial Office - University of Illinois Cancer Center     312-355-3046        
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202-5289
Contact: Clinical Trials Office - Indiana University Cancer Center     317-274-2552        
St. Vincent Indianapolis Hospital Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Clinical Trials Office - St. Vincent Indianapolis Hospital     317-338-2194        
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service     800-237-1225        
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160-7357
Contact: Clinical Trials Office - Kansas Masonic Cancer Research Instit     913-588-4709        
United States, Kentucky
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40232
Contact: Clinical Trials Office - Kosair Children's Hospital     502-629-5500     CancerResource@nortonhealthcare.org    
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of     859-257-3379        
United States, Louisiana
Tulane Cancer Center Office of Clinical Research Recruiting
Alexandria, Louisiana, United States, 71315-3198
Contact: Clinical Trials Office - Tulane Cancer Center     504-988-6121        
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Recruiting
Baltimore, Maryland, United States, 21215
Contact: Joseph M. Wiley     410-601-5864        
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce     410-955-8804     jhcccro@jhmi.edu    
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Suzanne Shusterman     617-632-4901        
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital     877-726-5130        
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute     313-576-9363        
Breslin Cancer Center at Ingham Regional Medical Center Recruiting
Lansing, Michigan, United States, 48910
Contact: Clinical Trials Office - Breslin Cancer Center at Ingham Regio     517-334-2765        
Butterworth Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503-2560
Contact: David S. Dickens     616-391-2086        
C.S. Mott Children's Hospital at University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109-0286
Contact: Clinical Trials Office - C.S. Mott Children's Hospital     800-865-1125        
CCOP - Kalamazoo Recruiting
Kalamazoo, Michigan, United States, 49007-5381
Contact: Jeffrey S. Lobel     269-341-6350        
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center     810-762-8057        
Van Elslander Cancer Center at St. John Hospital and Medical Center Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo     313-343-3166        
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Clinical Trials Office - Children's Hospitals and Clinics of M     612-813-5193        
Masonic Cancer Center at University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o     612-624-2620        
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Mississippi
University of Mississippi Cancer Clinic Recruiting
Jackson, Mississippi, United States, 39216-4505
Contact: Gail C. Megason     601-984-5220        
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Maxine Hetherington     816-234-3265        
Ellis Fischel Cancer Center at University of Missouri - Columbia Recruiting
Columbia, Missouri, United States, 65203
Contact: Clinical Trial Office - Ellis Fischel Cancer Center     573-882-7440        
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
St. Louis, Missouri, United States, 63110
Contact: Robert J. Hayashi     314-454-4118        
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ     800-999-5465        
United States, Nevada
CCOP - Nevada Cancer Research Foundation Recruiting
Las Vegas, Nevada, United States, 89109-2306
Contact: Jonathan Bernstein     702-732-0971        
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center     603-650-7609     cancerhelp@dartmouth.edu    
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey     732-235-8675        
Hackensack University Medical Center Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Clinical Trials Office - Hackensack University Medical Center     201-996-2879        
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Clinical Trials Office - Newark Beth Israel Medical Center     973-926-3136        
Overlook Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Hazem Mahmoud     973-971-6720        
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente     505-272-6972        
United States, New York
Albany Medical Center Hospital Recruiting
Albany, New York, United States, 12208-3419
Contact: Vikramjit S. Kanwar     518-262-5513x25265        
Albert Einstein Cancer Center at Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe     718-904-2730     aecc@aecom.yu.edu    
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute     877-275-7724        
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Birte Wistinghausen     212-241-7022        
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Fevzi Ozkaynak     914-493-7997        
NYU Cancer Institute at New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact: Elizabeth Raetz     212-263-8400        
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Barbara L. Asselin     585-275-2981        
Stony Brook University Cancer Center Recruiting
Stony Brook, New York, United States, 11794-9446
Contact: Clinical Trials Office - Stony Brook University Cancer Center     800-862-2215        
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi     315-464-5476        
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas     704-355-2884        
Duke Comprehensive Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center     888-275-3853        
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente     877-668-0683; 919-966-4432        
Mission Hospitals - Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus     828-213-4150        
Presbyterian Cancer Center at Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28233-3549
Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt     704-384-5369        
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive     336-713-6771        
United States, North Dakota
CCOP - MeritCare Hospital Recruiting
Fargo, North Dakota, United States, 58122
Contact: Nathan Kobrinsky     701-234-7544        
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308-1062
Contact: Clinical Trials Office - Akron Children's Hospital     330-543-3193        
Children's Medical Center - Dayton Recruiting
Dayton, Ohio, United States, 45404-1815
Contact: Emmett Broxson     937-641-3111        
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica     513-636-2799        
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente     866-223-8100        
Medical University of Ohio Cancer Center Recruiting
Toledo, Ohio, United States, 43614
Contact: Clinical Trials Office - Medical University of Ohio Cancer Cen     419-383-6583        
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205-2696
Contact: Amanda M. Termuhlen     614-722-3552        
Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106-5000
Contact: Yousif (Joe) H. Matloub     216-844-3345        
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp     405-271-5311        
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea     503-494-1080     trials@ohsu.edu    
Legacy Emanuel Hospital and Health Center and Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Clinical Trials Office - Legacy Emanuel Hospital and Health Ce     503-413-8199        
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104-9786
Contact: Richard Aplenc     267-426-7252        
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Clinical Trials Office - Children's Hospital of Pittsburgh     412-692-5573        
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute     570-271-5251        
Penn State Cancer Institute at Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Clinical Trials Office - Penn State Cancer Institute at Milton     717-531-3779     CTO@hmc.psu.edu    
United States, South Carolina
Greenville Hospital Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Clinical Trials Office - Greenville Hospital Cancer Center     864-241-6251        
United States, Tennessee
East Tennessee Children's Hospital Recruiting
Knoxville, Tennessee, United States, 37901
Contact: Ray C. Pais     865-541-8266        
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Clinical Trials Office - St. Jude Children's Research Hospital     901-595-4644        
T.C. Thompson Children's Hospital Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Manoo G. Bhakta     423-778-7289        
United States, Texas
CCOP - Scott and White Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Arlynn F. Mulne     254-724-2006        
Cook Children's Medical Center - Fort Worth Recruiting
Fort Worth, Texas, United States, 76104
Contact: Clinical Trials Office - Cook's Children's Medical Center     682-885-2103        
Covenant Children's Hospital Recruiting
Lubbock, Texas, United States, 79410
Contact: Latha Prasannan     806-725-4840        
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Clinical Trials Office - Dell Children's Medical Center of Cen     512-324-8022        
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Clinical Trials Office - Driscoll Children's Hospital     361-694-5311        
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Carl Lenarsky     972-566-6647x4439        
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229-3993
Contact: Michael S. Grimley     210-575-7268        
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a     866-460-4673; 214-648-7097        
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Paul Thomas     210-704-2187        
United States, Utah
Primary Children's Medical Center Recruiting
Salt Lake City, Utah, United States, 84113-1100
Contact: Phillip E. Barnette     801-662-4700        
United States, Virginia
Children's Hospital of The King's Daughters Recruiting
Norfolk, Virginia, United States, 23507-1971
Contact: Eric J. Lowe     757-668-7243        
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042-3300
Contact: Clinical Trials Office - Inova Fairfax Hospital     703-208-6650        
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kimberly P. Dunsmore     434-924-5105        
United States, Washington
Children's Hospital and Regional Medical Center - Seattle Recruiting
Seattle, Washington, United States, 98105
Contact: Julie R. Park     206-987-2106        
Madigan Army Medical Center - Tacoma Recruiting
Tacoma, Washington, United States, 98431
Contact: Melissa A. Forouhar     253-968-6144        
Mary Bridge Children's Hospital and Health Center - Tacoma Recruiting
Tacoma, Washington, United States, 98405
Contact: Ronald Louie     253-403-3481        
Providence Cancer Center at Sacred Heart Medical Center Recruiting
Spokane, Washington, United States, 99220-2555
Contact: Judy L. Felgenhauer     509-474-2777        
United States, West Virginia
West Virginia University Health Sciences Center - Charleston Recruiting
Charleston, West Virginia, United States, 25302
Contact: Allen R. Chauvenet     304-388-1552        
United States, Wisconsin
Marshfield Clinic - Marshfield Center Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center     800-782-1581 ext. 94457        
Midwest Children's Cancer Center at Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Michael E. Kelly     414-456-4170        
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer     920-433-8889        
Australia, New South Wales
Westmead Institute for Cancer Research at Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Geoffrey B. McCowage     61298452122        
Australia, Queensland
Royal Children's Hospital Recruiting
Brisbane, Queensland, Australia, 4029
Contact: Helen Irving     617-3636-8671        
Australia, South Australia
Women's and Children's Hospital Recruiting
North Adelaide, South Australia, Australia, 5006
Contact: Maria L. Kirby     61881617411        
Australia, Victoria
Royal Children's Hospital Recruiting
Parkville, Victoria, Australia, 3052
Contact: David Ashley     61393455652        
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia, 6001
Contact: Catherine Cole     011-6189340-8238        
Canada
Centre Hospitalier Universitaire de Quebec Recruiting
Quebec, Canada, G1V 4G2
Contact: Bruno Michon     418-656-4141X47191        
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Douglas R. Strother     403-955-7272        
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Sunil Jayantilal` S. Desai     780-407-8829        
Canada, British Columbia
Children's & Women's Hospital of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Mason C. Bond     604-875-2322        
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Rochelle Yanofsky     204-787-4163        
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre Recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: John (Jack) P. Hand     709-777-4799        
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Margaret C. Yhap     902-470-8778        
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Mariana P. Silva     613-5496666x3833        
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Jacqueline Halton     613-737-7600x2370        
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Sylvain Baruchel     416-813-7795        
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Carol A. Portwine     905-521-2100x73464        
Canada, Quebec
Hopital Sainte Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Yvan Samson     418-656-4141x47191        
Canada, Saskatchewan
Saskatoon Cancer Centre at the University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Kaiser Ali     306-655-2744        
Puerto Rico
San Jorge Children's Hospital Recruiting
Santurce, Puerto Rico, 00912
Contact: Luis A. Clavell     787-728-1575        
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Sheri L. Spunt, MD St. Jude Children's Research Hospital
Investigator: Karyn A. Goodman, MD Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers: CDR0000483702, COG-ARST0332
Study First Received: June 28, 2006
Last Updated: November 25, 2009
ClinicalTrials.gov Identifier: NCT00346164     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult malignant hemangiopericytoma
adult malignant mesenchymoma
adult neurofibrosarcoma
adult alveolar soft-part sarcoma
adult angiosarcoma
adult epithelioid sarcoma
adult extraskeletal chondrosarcoma
adult extraskeletal osteosarcoma
adult fibrosarcoma
adult leiomyosarcoma
adult liposarcoma
adult synovial sarcoma
childhood alveolar soft-part sarcoma
childhood angiosarcoma
childhood epithelioid sarcoma
childhood fibrosarcoma
childhood leiomyosarcoma
childhood liposarcoma
childhood synovial sarcoma
dermatofibrosarcoma protuberans
metastatic childhood soft tissue sarcoma
nonmetastatic childhood soft tissue sarcoma
stage I adult soft tissue sarcoma
stage II adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
adult malignant fibrous histiocytoma
localized childhood malignant fibrous histiocytoma of bone
metastatic childhood malignant fibrous histiocytoma of bone
chondrosarcoma

Additional relevant MeSH terms:
Histiocytoma, Malignant Fibrous
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Histiocytoma, Benign Fibrous
Antineoplastic Agents
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Neoplasms, Connective and Soft Tissue
Neoplasms
Ifosfamide
Histiocytoma
Therapeutic Uses
Sarcoma
Antineoplastic Agents, Alkylating
Neoplasms, Connective Tissue
Neoplasms, Fibrous Tissue
Alkylating Agents

ClinicalTrials.gov processed this record on November 27, 2009