Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

Basic Trial Information

Objectives

Primary

1. Define a risk-based treatment strategy comprising observation only, adjuvant radiotherapy, or adjuvant chemoradiotherapy or neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy in young patients with non-rhabdomyosarcoma soft tissue sarcoma (NRSTS).
2. Assess event-free and overall survival of patients treated with these regimens.
3. Assess the pattern of treatment failure in these patients.

Secondary

1. Assess the feasibility of a neoadjuvant chemoradiotherapy approach in patients with intermediate- or high-risk NRSTS.
2. Assess the imaging and pathologic responses to neoadjuvant chemoradiotherapy in patients with intermediate- or high-risk NRSTS.
3. Correlate imaging and pathologic response with clinical outcomes in patients with intermediate- or high-risk disease who undergo neoadjuvant chemoradiotherapy.
4. Prospectively define clinical prognostic factors associated with event-free survival, overall survival, local recurrence, and distant recurrence in these patients.
5. Correlate patient outcomes with findings of biologic studies performed on tissue specimens collected on protocol COG-D9902 from these patients.
6. Determine whether the diagnosis and histologic grade of NRSTS assigned by the enrolling institution correlates with the diagnosis and histologic grade established by central expert pathology reviewers.
7. Compare the Pediatric Oncology Group (POG) and Fédération Nationale des Centres de Lutte Contre le Cancer (French Federation of Cancer Centers [FNCLCC]) pathologic grading systems to determine which better correlates with clinical outcomes.

Entry 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

• Tumors arising in bone 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)

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

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
• 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)* or serum creatinine based on age and/or gender as follows:
  • 0.4 mg/dL (1 month to < 6 months of age)
  • 0.5 mg/dL (6 months to < 1 year of age)
  • 0.6 mg/dL (1 year to < 2 years of age)
  • 0.8 mg/dL (2 years to < 6 years of age)
  • 1.0 mg/dL (6 years to < 10 years of age)
  • 1.2 mg/dL (10 years to < 13 years of age)
  • 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 years to < 16 years of age)
  • 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years 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 (patients undergoing radiotherapy and/or chemotherapy)
  • 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
• Negative pregnancy test
• 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]

Expected Enrollment

A total of 600 patients will be accrued for this study.

Outcomes

Long-term survival at 5 years
Event-free and overall survival at 5 years

Local tumor control at 5 years
Feasibility of neoadjuvant chemoradiotherapy
Imaging and pathologic response after neoadjuvant chemoradiotherapy, and their relationship to survival and local outcomes

Outline

This is a multicenter study. Patients are divided into 3 risk groups according to presence of metastatic disease (yes vs no), status of prior surgery (resected vs unresected), grade of tumor (low vs high), and size of primary tumor (≤ 5 cm vs > 5 cm). Patients are assigned to different treatment regimens based on disease extent (nonmetastatic vs metastatic), tumor size (≤ 5 cm vs > 5 cm), extent of resection of primary tumor (resected vs unresected), extent of resection of metastases (complete or microscopic residual vs gross residual), microscopic tumor margins (negative vs positive), and tumor grade (low vs high).

• Group 1 (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 regimen A. Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to regimen B.
  • Regimen A (observation only): Patients undergo observation only.

  • Regimen B (adjuvant radiotherapy): Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.

• Group 2 (intermediate risk [nonmetastatic, resected or unresected disease]): Patients with grossly resected, high-grade tumor > 5 cm (in maximum diameter) are assigned to regimen C. Patients with unresected tumor are assigned to regimen D.
  • Regimen C (adjuvant chemoradiotherapy): Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 1, 4, 7, 10, 13, and 16 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 1, 4, 13, 16, and 19. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy*.

     [Note: *Patients who receive brachytherapy will initiate radiotherapy in Week 1. If brachytherapy is administered, chemotherapy should begin within 2 weeks of completion of brachytherapy and the Weeks 1 and 19 doxorubicin should be given instead at Weeks 7 and 10.]

  • Regimen D (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy):
    • Neoadjuvant chemoradiotherapy and surgery: Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 1, 4, 7, and 10 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 1 and 4. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy**. Patients undergo surgical resection in week 13.

       [Note: **Patients with primary hepatic tumors do not receive radiotherapy in week 4.]

    • Adjuvant chemotherapy with or without radiotherapy: Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 16 and 19 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 16, 19***, and 22. Beginning in week 16, patients achieving gross total resection with positive microscopic margins undergo a total of 6 fractions of adjuvant radiotherapy. Patients achieving less than total gross resection undergo a total of 11 fractions of adjuvant radiotherapy. Patients achieving total gross resection with negative microscopic margins do not receive adjuvant radiotherapy.

       [Note: ***Patients who receive adjuvant radiotherapy in week 16 receive doxorubicin hydrochloride in week 25 instead of week 19.]

• Group 3 (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, and metastatic disease 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.

In all groups, treatment continues in the absence of disease progression.

After completing study treatment, patients are followed periodically for at least 5 years.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Sheri Spunt, MD, Protocol chair		Ph: 901-595-3984
Karyn Goodman, MD, Protocol co-chair		Ph: 650-724-3547; 800-756-9000

U.S.A.
Alabama
	Birmingham
	UAB Comprehensive Cancer Center
		Clinical Trials Office - UAB Comprehensive Cancer Center	Ph:  205-934-0309
Arizona
	Phoenix
	Phoenix Children's Hospital
		Jessica Boklan	Ph:  602-546-0920
	Tucson
	Arizona Cancer Center at University of Arizona Health Sciences Center
		Clinical Trials Office - Arizona Cancer Center at University of Arizona Health Sciences Center	Ph:  520-626-9008
Arkansas
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Ph:  501-686-8274
California
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Center	Ph:  800-826-4673
			Email: becomingapatient@coh.org
	Loma Linda
	Loma Linda University Cancer Institute at Loma Linda University Medical Center
		Clinical Trials Office - Loma Linda University Cancer Institute	Ph:  909-558-3375
	Long Beach
	Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
		Jerry Finklestein	Ph:  562-728-5000
	Los Angeles
	Childrens Hospital Los Angeles
		Leo Mascarenhas	Ph:  323-361-2529
	Jonsson Comprehensive Cancer Center at UCLA
		Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA	Ph:  888-798-0719
	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
		Fataneh (Fae) Majlessipour	Ph:  310-423-4423
	Southern California Permanente Medical Group
		Robert Cooper	Ph:  323-783-5307
	Madera
	Children's Hospital Central California
		Vonda Crouse	Ph:  559-353-5480
	Oakland
	Children's Hospital and Research Center Oakland
		Clinical Trial Office - Children's Hospital and Research Center Oakland	Ph:  510-450-7600
	Orange
	Children's Hospital of Orange County
		Violet Shen	Ph:  714-532-8636
	Palo Alto
	Lucile Packard Children's Hospital at Stanford University Medical Center
		Neyssa Marina	Ph:  650-723-5535
	Sacramento
	Kaiser Permanente Medical Center - Oakland
		Vincent Kiley	Ph:  916-474-2326
	San Diego
	Rady Children's Hospital - San Diego
		Clinical Trials Office - Rady Children's Hospital - San Diego	Ph:  858-966-5934
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222
Colorado
	Aurora
	Children's Hospital Colorado Center for Cancer and Blood Disorders
		Kelly Maloney	Ph:  720-777-6673
	Denver
	Presbyterian - St. Luke's Medical Center
		Clinical Trials Office - Presbyterian - St. Luke's Medical Center	Ph:  303-839-6000
Connecticut
	Hartford
	Connecticut Children's Medical Center
		Clinical Trials Office - Connecticut Children's Medical Center	Ph:  860-545-9967
	New Haven
	Yale Cancer Center
		Clinical Trials Office - Yale Cancer Center	Ph:  203-785-5702
Delaware
	Wilmington
	Alfred I. duPont Hospital for Children
		Clinical Trials Office - Alfred I. duPont Hospital for Children	Ph:  302-651-5755
District of Columbia
	Washington
	Children's National Medical Center
		Clinical Trials Office - Children's National Medical Center	Ph:  202-884-2549
	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
		Clinical Trials Office - Lombardi Comprehensive Cancer Center	Ph:  202-444-0381
Florida
	Fort Lauderdale
	Broward General Medical Center Cancer Center
		Clinical Trials Office - Broward General Medical Center Cancer Center	Ph:  954-355-5346
	Fort Myers
	Lee Cancer Care of Lee Memorial Health System
		Clinical Trials Office - Lee Cancer Care of Lee Memorial Health System	Ph:  877-680-0008
	Gainesville
	University of Florida Shands Cancer Center
		Clinical Trials Office - University of Florida Shands Cancer Center	Ph:  888-254-7581
	Hollywood
	Memorial Cancer Institute at Memorial Regional Hospital
		Clinical Trials Office - Memorial Cancer Institute	Ph:  954-985-3443
	Jacksonville
	Nemours Children's Clinic
		Eric Sandler	Ph:  904-697-3793
	Miami
	Baptist-South Miami Regional Cancer Program
		Doured Daghistani	Ph:  305-274-1662
	Miami Children's Hospital
		Enrique Escalon	Ph:  305-662-8360x4960
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service	Ph:  866-574-5124
			Email: Sylvester@emergingmed.com
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clinical Trials Office - Florida Hospital Cancer Institute	Ph:  407-303-5623
	M.D. Anderson Cancer Center at Orlando
		Vincent Giusti	Ph:  321-841-8588
	Nemours Children's Clinic - Orlando
		Ramamoorthy Nagasubramanian	Ph:  407-650-7230
	Pensacola
	Nemours Children's Clinic - Pensacola
		Jeffrey Schwartz	Ph:  850-505-4790
	Saint Petersburg
	All Children's Hospital
		Gregory Hale	Ph:  727-767-4176
	Tampa
	St. Joseph's Cancer Institute at St. Joseph's Hospital
		Clinical Trials Office - St. Joseph's Cancer Institute	Ph:  800-882-4123
	West Palm Beach
	Kaplan Cancer Center at St. Mary's Medical Center
		Narayana Gowda	Ph:  561-844-6363
Georgia
	Atlanta
	AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
		Todd Cooper	Ph:  404-785-1838
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute	Ph:  912-350-8568
Hawaii
	Honolulu
	Cancer Research Center of Hawaii
		Clinical Trials Office - Cancer Research Center of Hawaii	Ph:  808-586-2979
	Tripler AMC
	Tripler Army Medical Center
		Melissa Forouhar	Ph:  253-968-6144
Idaho
	Boise
	Mountain States Tumor Institute at St. Luke's Regional Medical Center
		Eugenia Chang	Ph:  208-381-2731
Illinois
	Chicago
	Children's Memorial Hospital - Chicago
		Stewart Goldman	Ph:  773-880-3270
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	University of Illinois Cancer Center
		Clinical Trial Office - University of Illinois Cancer Center	Ph:  312-355-3046
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph:  708-226-4357
	Oak Lawn
	Keyser Family Cancer Center at Advocate Hope Children's Hospital
		Sharad Salvi	Ph:  708-684-4094
	Park Ridge
	Advocate Lutheran General Cancer Care Center
		Clinical Trials Office - Advocate Lutheran General Cancer Care Center	Ph:  847-384-3621
	Peoria
	Saint Jude Midwest Affiliate
		Pedro De Alarcon	Ph:  309-655-4242
	Springfield
	Simmons Cooper Cancer Institute
		Clinical Trials Office - Simmons Cooper Cancer Institute	Ph:  217-545-7929
Indiana
	Indianapolis
	Riley's Children Cancer Center at Riley Hospital for Children
		James Croop	Ph:  317-274-8784
	St. Vincent Indianapolis Hospital
		Clinical Trials Office - St. Vincent Indianapolis Hospital	Ph:  317-338-2194
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
Kentucky
	Lexington
	Lucille P. Markey Cancer Center at University of Kentucky
		Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center	Ph:  859-257-3379
	Louisville
	Kosair Children's Hospital
		Clinical Trials Office - Kosair Children's Hospital	Ph:  502-629-5500
			Email: CancerResource@nortonhealthcare.org
Louisiana
	Alexandria
	Tulane Cancer Center Office of Clinical Research
		Clinical Trials Office - Tulane Cancer Center	Ph:  504-988-6121
Maine
	Bangor
	CancerCare of Maine at Eastern Maine Medical Center
		Clinical Trials Office - CancerCare of Maine	Ph:  207-973-4274
	Scarborough
	Maine Children's Cancer Program at Barbara Bush Children's Hospital
		Eric Larsen	Ph:  207-396-7565
Maryland
	Baltimore
	Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
		Joseph Wiley	Ph:  410-601-6266
	Greenebaum Cancer Center at University of Maryland Medical Center
		Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center	Ph:  800-888-8823
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Ph:  410-955-8804
			Email: jhcccro@jhmi.edu
	Bethesda
	National Naval Medical Center
		Melissa Forouhar	Ph:  253-968-6144
Massachusetts
	Boston
	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
		Carlos Rodriguez-Galindo	Ph:  617-632-4580
	Massachusetts General Hospital
		Clinical Trials Office - Massachusetts General Hospital	Ph:  877-726-5130
	Springfield
	Baystate Regional Cancer Program at D'Amour Center for Cancer Care
		Contact Person	Ph:  413-794-9338
	Worcester
	UMASS Memorial Cancer Center - University Campus
		Christopher Keuker	Ph:  508-856-4225
Michigan
	Ann Arbor
	C.S. Mott Children's Hospital at University of Michigan Medical Center
		Clinical Trials Office - C.S. Mott Children's Hospital	Ph:  1-800-865-1125
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Clinical Trials Office - Barbara Ann Karmanos Cancer Institute	Ph:  313-576-9363
	Flint
	Hurley Medical Center
		Clinical Trials Office - Hurley Medical Center	Ph:  810-762-8057
	Grand Rapids
	Helen DeVos Children's Hospital at Spectrum Health
		Clinical Trials Office - Helen DeVos Children's Hospital	Ph:  616-391-3050
	Grosse Pointe Woods
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center	Ph:  313-343-3166
	Kalamazoo
	CCOP - Kalamazoo
		Jeffrey Lobel	Ph:  269-341-6350
Minnesota
	Minneapolis
	Children's Hospitals and Clinics of Minnesota - Minneapolis
		Clinical Trials Office - Children's Hospitals and Clinics of Minnesota	Ph:  612-813-5193
	Masonic Cancer Center at University of Minnesota
		Clinical Trials Office - Masonic Cancer Center at University of Minnesota	Ph:  612-624-2620
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Gail Megason	Ph:  601-984-5220
Missouri
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Clinical Trial Office - Ellis Fischel Cancer Center	Ph:  573-882-7440
	Kansas City
	Children's Mercy Hospital
		Maxine Hetherington	Ph:  816-234-3265
	Saint Louis
	David C. Pratt Cancer Center at St. John's Mercy
		Clinical Trials Office - David C. Pratt Cancer Center at St. John's Mercy	Ph:  314-251-6770
	St. Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Robert Hayashi	Ph:  314-454-2041
Nebraska
	Omaha
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Ph:  800-999-5465
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		Jonathan Bernstein	Ph:  702-732-1493
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Clinical Trials Office - Norris Cotton Cancer Center	Ph:  603-650-7609
			Email: cancerhelp@dartmouth.edu
New Jersey
	Hackensack
	Hackensack University Medical Center Cancer Center
		Clinical Trials Office - Hackensack University Medical Center Cancer Center	Ph:  201-996-2879
	Morristown
	Overlook Hospital
		Steven Halpern	Ph:  973-971-6720
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Clinical Trials Office - Cancer Institute of New Jersey	Ph:  732-235-8675
	Saint Peter's University Hospital
		Stanley Calderwood	Ph:  732-745-6674
	Newark
	Newark Beth Israel Medical Center
		Clinical Trials Office - Newark Beth Israel Medical Center	Ph:  973-926-3136
	Paterson
	St. Joseph's Hospital and Medical Center
		Mary Bonilla	Ph:  973-754-3349
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Center	Ph:  505-272-6972
New York
	Albany
	Albany Medical Center Hospital
		Vikramjit Kanwar	Ph:  518-262-5513x25265
	Bronx
	Albert Einstein Cancer Center at Albert Einstein College of Medicine
		Clinical Trials Office - Albert Einstein Cancer Center at Albert Einstein College of Medicine	Ph:  718-904-2730
			Email: aecc@aecom.yu.edu
	Brooklyn
	Brooklyn Hospital Center
		Swayamprabha Sadanandan	Ph:  718-250-6074
	Maimonides Cancer Center at Maimonides Medical Center
		Contact Person	Ph:  718-765-2520
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	New Hyde Park
	Schneider Children's Hospital
		Arlene Redner	Ph:  718-470-3460
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	Ph:  212-305-8615
	Mount Sinai Medical Center
		Birte Wistinghausen	Ph:  212-241-7022
	NYU Cancer Institute at New York University Medical Center
		Elizabeth Raetz	Ph:  212-263-8400
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Lisa Hackney	Ph:  585-275-2981
	Stony Brook
	Stony Brook University Cancer Center
		Clinical Trials Office - Stony Brook University Cancer Center	Ph:  800-862-2215
	Syracuse
	SUNY Upstate Medical University Hospital
		Clinical Trials Office - SUNY Upstate Medical University Hospital	Ph:  315-464-5476
	Valhalla
	New York Medical College
		Mehmet Ozkaynak	Ph:  914-493-7997
North Carolina
	Asheville
	Mission Hospitals - Memorial Campus
		Clinical Trials Office - Mission Hospitals - Memorial Campus	Ph:  828-213-4150
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Center	Ph:  877-668-0683; 919-966-4432
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center	Ph:  704-355-2884
	Presbyterian Cancer Center at Presbyterian Hospital
		Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital	Ph:  704-384-5369
	Durham
	Duke Cancer Institute
		Clinical Trials Office - Duke Cancer Institute	Ph:  888-275-3853
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771
North Dakota
	Fargo
	CCOP - MeritCare Hospital
		Nathan Kobrinsky	Ph:  701-234-7544
Ohio
	Akron
	Akron Children's Hospital
		Clinical Trials Office - Akron Children's Hospital	Ph:  330-543-3193
	Cincinnati
	Cincinnati Children's Hospital Medical Center
		Clinical Trials Office - Cincinnati Children's Hospital Medical Center	Ph:  513-636-2799
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
	Rainbow Babies and Children's Hospital
		Yousif (Joe) Matloub	Ph:  216-844-3345
	Columbus
	Nationwide Children's Hospital
		Laura Martin	Ph:  614-722-3582
	Dayton
	Dayton Children's - Dayton
		Emmett Broxson	Ph:  937-641-3111
	Toledo
	Mercy Children's Hospital
		Rama Jasty	Ph:  419-251-8215
	Toledo Hospital
		Clinical Trials Office - Toledo Hospital	Ph:  419-824-1842
	Youngstown
	Tod Children's Hospital
		Clinical Trials Office - Tod Children's Hospital	Ph:  330-884-3955
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Rene McNall-Knapp	Ph:  405-271-5311
Oregon
	Portland
	Knight Cancer Institute at Oregon Health and Science University
		Clinical Trials Office - Knight Cancer Institute at Oregon Health and Science University	Ph:  503-494-1080
			Email: trials@ohsu.edu
	Legacy Emanuel Children's Hospital
		Clinical Trials Office - Legacy Emanuel Children's Hospital	Ph:  503-413-2560
Pennsylvania
	Bethlehem
	Lehigh Valley Hospital - Muhlenberg
		Philip Monteleone	Ph:  484-884-3333
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Clinical Trials Office - Geisinger Cancer Institute	Ph:  570-271-5251
	Hershey
	Penn State Children's Hospital
		John Kuttesch	Ph:  717-531-6012
	Philadelphia
	Children's Hospital of Philadelphia
		Elizabeth Fox	Ph:  267-425-3010
	Pittsburgh
	Children's Hospital of Pittsburgh of UPMC
		Clinical Trials Office - Children's Hospital of Pittsburgh	Ph:  412-692-7056
Rhode Island
	Providence
	Rhode Island Hospital Comprehensive Cancer Center
		Clinical Trials Office - Rhode Island Hospital Comprehensive Cancer Center	Ph:  401-444-1488
South Carolina
	Columbia
	Palmetto Health South Carolina Cancer Center
		Clinical Trials Office - Palmetto Health South Carolina Cancer Center	Ph:  803-434-3680
	Greenville
	Greenville Hospital Cancer Center
		Clinical Trials Office - Greenville Hospital Cancer Center	Ph:  864-241-6251
South Dakota
	Sioux Falls
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph:  605-328-1367
Tennessee
	Chattanooga
	T.C. Thompson Children's Hospital
		Manoo Bhakta	Ph:  423-778-7289
	Knoxville
	East Tennessee Children's Hospital
		Ray Pais	Ph:  865-541-8266
	Memphis
	St. Jude Children's Research Hospital
		Clinical Trials Office - St. Jude Children's Research Hospital	Ph:  901-595-4644
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  800-811-8480
Texas
	Amarillo
	Texas Tech University Health Sciences Center School of Medicine - Amarillo
		Osvaldo Regueira	Ph:  806-354-5434x282
	Austin
	Dell Children's Medical Center of Central Texas
		Clinical Trials Office - Dell Children's Medical Center of Central Texas	Ph:  512-324-8022
	Corpus Christi
	Driscoll Children's Hospital
		Clinical Trials Office - Driscoll Children's Hospital	Ph:  361-694-5311
	Dallas
	Medical City Dallas Hospital
		Carl Lenarsky	Ph:  972-566-6647x4439
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Ph:  866-460-4673; 214-648-7097
	Fort Sam Houston
	Brooke Army Medical Center
		Clinical Trials Office - Brooke Army Medical Center	Ph:  210-916-4837
	Fort Worth
	Cook Children's Medical Center - Fort Worth
		Clinical Trials Office - Cook's Children's Medical Center	Ph:  682-885-2103
	Houston
	Baylor University Medical Center - Houston
		Patrick Thompson	Ph:  832-824-4029
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
	Lubbock
	Covenant Children's Hospital
		Latha Prasannan	Ph:  806-725-4840
	San Antonio
	Methodist Children's Hospital of South Texas
		Jaime Estrada	Ph:  210-575-7268
	University of Texas Health Science Center at San Antonio
		Paul Thomas	Ph:  210-567-7477
	Temple
	CCOP - Scott and White Hospital
		Guy Grayson	Ph:  254-724-2006
Utah
	Salt Lake City
	Primary Children's Medical Center
		Phillip Barnette	Ph:  801-662-4700
Vermont
	Burlington
	Fletcher Allen Health Care - University Health Center Campus
		Clinical Trials Office - Fletcher Allen Health Care	Ph:  802-656-8990
Virginia
	Charlottesville
	University of Virginia Cancer Center
		Kimberly Dunsmore	Ph:  434-924-5105
	Falls Church
	Inova Fairfax Hospital
		Clinical Trials Office - Inova Fairfax Hospital	Ph:  703-208-6650
	Norfolk
	Children's Hospital of The King's Daughters
		Eric Lowe	Ph:  757-668-7243
	Richmond
	Virginia Commonwealth University Massey Cancer Center
		Clinical Trials Office -Virginia Commonwealth University Massey Cancer Center	Ph:  804-628-1939
Washington
	Seattle
	Children's Hospital and Regional Medical Center - Seattle
		Julie Park	Ph:  206-987-2106
	Spokane
	Providence Cancer Center at Sacred Heart Medical Center
		Judy Felgenhauer	Ph:  509-474-2777
	Tacoma
	Mary Bridge Children's Hospital and Health Center - Tacoma
		Robert Irwin	Ph:  253-403-3481
West Virginia
	Charleston
	West Virginia University Health Sciences Center - Charleston
		Allen Chauvenet	Ph:  304-388-1552
	Huntington
	Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
		Oncology Research Supervisor	Ph:  304-399-6617
Wisconsin
	Green Bay
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Clinical Trials Office - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Ph:  608-262-5223
	Marshfield
	Marshfield Clinic - Marshfield Center
		Clinical Trials Office - Marshfield Clinic - Marshfield Center	Ph:  800-782-1581 ext. 94457
	Milwaukee
	Midwest Children's Cancer Center at Children's Hospital of Wisconsin
		Michael Kelly	Ph:  414-456-4170
Australia
New South Wales
	Randwick
	Sydney Children's Hospital
		Draga Barbaric	Ph:  612-9382-2970
	Westmead
	Children's Hospital at Westmead
		Geoffrey McCowage	Ph:  61298452122
Queensland
	Brisbane
	Royal Children's Hospital
		Helen Irving	Ph:  617-3636-8671
South Australia
	North Adelaide
	Women's and Children's Hospital
		Maria Kirby	Ph:  61881617411
Victoria
	Parkville
	Royal Children's Hospital
		Francoise Mechinaud	Ph:  613-9345-4893
Western Australia
	Perth
	Princess Margaret Hospital for Children
		Catherine Cole	Ph:  011-6189340-8238
Canada
Alberta
	Calgary
	Alberta Children's Hospital
		Douglas Strother	Ph:  403-955-7272
	Edmonton
	University of Alberta Hospital
		Sunil Jayantilal` Desai	Ph:  780-407-8829
British Columbia
	Vancouver
	Children's and Women's Hospital of British Columbia
		Caron Strahlendorf	Ph:  604-875-3576
Manitoba
	Winnipeg
	CancerCare Manitoba
		Rochelle Yanofsky	Ph:  204-787-4163
Newfoundland and Labrador
	St. John's
	Janeway Children's Health and Rehabilitation Centre
		Lisa Anne Goodyear	Ph:  709-777-4303
Nova Scotia
	Halifax
	IWK Health Centre
		Margaret Yhap	Ph:  902-470-8778
Ontario
	Hamilton
	McMaster Children's Hospital at Hamilton Health Sciences
		Carol Portwine	Ph:  905-521-2100x73464
	Kingston
	Cancer Centre of Southeastern Ontario at Kingston General Hospital
		Mariana Silva	Ph:  613-5496666x3833
	Ottawa
	Children's Hospital of Eastern Ontario
		Jacqueline Halton	Ph:  613-737-7600x2370
	Toronto
	Hospital for Sick Children
		Sylvain Baruchel	Ph:  416-813-7795
Quebec
	Montreal
	Hopital Sainte Justine
		Yvan Samson	Ph:  514-345-4969
	Montreal Children's Hospital at McGill University Health Center
		Sharon Abish	Ph:  514-412-4400x22219
	Quebec
	Centre Hospitalier Universitaire de Quebec
		Bruno Michon	Ph:  418-656-4141X47191
Saskatchewan
	Saskatoon
	Saskatoon Cancer Centre at the University of Saskatchewan
		Christopher Mpofu	Ph:  306-655-2744
Netherlands
	Nijmegen
	Universitair Medisch Centrum St. Radboud - Nijmegen
		Contact Person	Ph:  31-24-361-5215
New Zealand
	Auckland
	Starship Children's Health
		Lochie Teague	Ph:  649-307-4949x22423
Puerto Rico
	Santurce
	San Jorge Children's Hospital
		Luis Clavell	Ph:  787-728-1575

Related Information

PDQ® clinical trial COG-D9902

Registry Information
Official Title		Risk-Based Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS) in Patients Under 30 years of Age
Trial Start Date		2007-02-05
Trial Completion Date		2012-03-03 (estimated)
Registered in ClinicalTrials.gov		NCT00346164
Date Submitted to PDQ		2006-05-01
Information Last Verified		2012-02-09
NCI Grant/Contract Number		CA98543

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