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| 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 |
| 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 |
DISEASE CHARACTERISTICS:
Newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma (STS), confirmed by central pathology review via concurrent enrollment on protocol COG-D9902
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:
Fibroblastic/myofibroblastic tumors, including any of the following:
So-called fibrohistiocytic tumors, including any of the following:
Chondro-osseous tumors of any of the following types:
Tumors of uncertain differentiation, including any of the following:
Dermatofibrosarcoma protuberans meeting both of the following criteria:
Gross resection of the primary tumor ≤ 42 days prior to enrollment required except if any of the following circumstances apply:
High-grade tumor with metastases
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*
PATIENT CHARACTERISTICS:
Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Hide Study 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 | |
| Study Chair: | Sheri L. Spunt, MD | St. Jude Children's Research Hospital |
| Investigator: | Karyn A. Goodman, MD | Stanford University |
More Information
| 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 |
|
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 |
|
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 |