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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003994 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. It is not yet known which chemotherapy regimen is most effective for children and young adults with liver cancer.
PURPOSE: This randomized phase III trial is studying giving combination chemotherapy together with amifostine to see how well it works compared to combination chemotherapy alone in treating patients with liver cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Drug: cisplatin Drug: fluorouracil Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: conventional surgery |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Intergroup Protocol for Treatment of Children With Hepatoblastoma |
| Estimated Enrollment: | 356 |
| Study Start Date: | March 1993 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
NOTE: * Arm II (amifostine) closed to accrual as of 11-25-03; arm IV (amifostine) closed to accrual as of 4-5-02
OUTLINE: This is a randomized study. Patients are stratified according to disease stage (stage I pure fetal histology vs stage I other histology or stage II [stage II closed to accrual as of 11-25-03] vs stage III or IV [stages III and IV closed to accrual as of 11-25-03]). Patients are randomized to one of four treatment arms. (Arms III and IV closed to accrual as of 4-5-02) (Arm II closed to accrual as of 11-25-03)
All patients undergo surgical resection or attempted resection of tumor. Patients with pure fetal histology achieving complete tumor resection receive no further treatment. All other patients receive postoperative chemotherapy.
Treatment repeats every 3 weeks for 4 courses in arms I and II (arm II closed to accrual as of 11-25-03) and every 4 weeks for 4 courses in arms III and IV (arms III and IV closed to accrual as of 4-5-02) in the absence of disease progression or unacceptable toxicity. Patients with stage III or IV disease (stages III and IV closed to accrual as of 11-25-03) undergo second look surgery and receive 2 additional courses of chemotherapy if achieving complete response after surgery.
Patients are followed monthly for 6 months, every 2 months for 2 years, every 3 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 356 patients will be accrued for this study within 5.5 years.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven hepatoblastoma
Stratum 1 (stage I):
Stratum 2 (stages I or II) (stage II closed to accrual as of 11-25-03), meeting 1 of the following criteria:
Stratum 3 (stages III or IV) (stages III and IV closed to accrual as of 11-25-03), meeting 1 of the following criteria:
Unresectable tumors
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| University of South Alabama Mitchell Cancer Institute | |
| Mobile, Alabama, United States, 36604 | |
| United States, Arizona | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724-5024 | |
| Phoenix Children's Hospital | |
| Phoenix, Arizona, United States, 85016-7710 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Children's Hospital and Research Center - Oakland | |
| Oakland, California, United States, 94609-1809 | |
| Children's Hospital Central California | |
| Madera, California, United States, 93638-8762 | |
| Childrens Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | |
| Long Beach, California, United States, 90801 | |
| Kaiser Permanente Medical Center - Oakland | |
| Sacramento, California, United States, 95825 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Southern California Permanente Medical Group | |
| Downey, California, United States, 90242-2814 | |
| Stanford Comprehensive Cancer Center at Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| Sutter Cancer Center | |
| Sacramento, California, United States, 95816 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| United States, Colorado | |
| Children's Hospital Cancer Center | |
| Denver, Colorado, United States, 80218-1088 | |
| United States, Connecticut | |
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06360-2875 | |
| Yale Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| All Children's Hospital | |
| St. Petersburg, Florida, United States, 33701 | |
| Memorial Cancer Institute at Memorial Regional Hospital | |
| Hollywood, Florida, United States, 33021 | |
| Broward General Medical Center Cancer Center | |
| Ft. Lauderdale, Florida, United States, 33316 | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | |
| Orlando, Florida, United States, 32803-1273 | |
| Lee Cancer Care of Lee Memorial Health System | |
| Fort Myers, Florida, United States, 33901 | |
| Baptist-South Miami Regional Cancer Program | |
| Miami, Florida, United States, 33176 | |
| Miami Children's Hospital | |
| Miami, Florida, United States, 33155 | |
| Nemours Children's Clinic - Orlando | |
| Orlando, Florida, United States, 32806 | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | |
| Tampa, Florida, United States, 33607 | |
| University of Florida Shands Cancer Center | |
| Gainesville, Florida, United States, 32610-0232 | |
| United States, Georgia | |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | |
| Savannah, Georgia, United States, 31403-3089 | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Idaho | |
| St. Luke's Mountain States Tumor Institute - Boise | |
| Boise, Idaho, United States, 83712-6297 | |
| United States, Illinois | |
| Advocate Christ Medical Center | |
| Oak Lawn, Illinois, United States, 60453 | |
| Cancer Care Center at Advocate Lutheran Hospital | |
| Park Ridge, Illinois, United States, 60068-1174 | |
| Children's Memorial Hospital - Chicago | |
| Chicago, Illinois, United States, 60614 | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62794-9620 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| St. Vincent Indianapolis Hospital | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Iowa | |
| Blank Children's Hospital | |
| Des Moines, Iowa, United States, 50309 | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1083 | |
| United States, Kansas | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Kentucky | |
| Kosair Children's Hospital | |
| Louisville, Kentucky, United States, 40232 | |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | |
| Lexington, Kentucky, United States, 40536-0293 | |
| United States, Louisiana | |
| Children's Hospital of New Orleans | |
| New Orleans, Louisiana, United States, 70118 | |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| Tulane Cancer Center | |
| Alexandria, Louisiana, United States, 71315-3198 | |
| United States, Maine | |
| CancerCare of Maine at Eastern Maine Medial Center | |
| Bangor, Maine, United States, 04401 | |
| Maine Children's Cancer Program | |
| Scarborough, Maine, United States, 04074-9308 | |
| United States, Maryland | |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | |
| Baltimore, Maryland, United States, 21215 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Breslin Cancer Center at Ingham Regional Medical Center | |
| Lansing, Michigan, United States, 48910 | |
| C.S. Mott Children's Hospital at University of Michigan | |
| Ann Arbor, Michigan, United States, 48109-0238 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-5341 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Spectrum Health Hospital - Butterworth Campus | |
| Grand Rapids, Michigan, United States, 49503-2560 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| United States, Minnesota | |
| Children's Hospitals and Clinics of Minneapolis | |
| Minneapolis, Minnesota, United States, 55404 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| University of Minnesota Medical Center & Children's Hospital - Fairview | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Cardinal Glennon Children's Hospital | |
| St. Louis, Missouri, United States, 63104 | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Siteman Cancer Center at Barnes-Jewish Hospital | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Children's Hospital of Omaha | |
| Omaha, Nebraska, United States, 68114-4113 | |
| United States, Nevada | |
| Sunrise Hospital and Medical Center | |
| Las Vegas, Nevada, United States, 89109-2306 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Hackensack University Medical Center Cancer Center | |
| Hackensack, New Jersey, United States, 07601 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| Overlook Hospital | |
| Morristown, New Jersey, United States, 07962 | |
| St. Barnabas Medical Center Cancer Center | |
| Livingston, New Jersey, United States, 07039 | |
| St. Joseph's Hospital and Medical Center | |
| Paterson, New Jersey, United States, 07503 | |
| United States, New Mexico | |
| University of New Mexico Cancer Research and Treatment Center | |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Maimonides Cancer Center at Maimonides Medical Center | |
| Brooklyn, New York, United States, 11219 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| NYU Cancer Institute at New York University Medical Center | |
| New York, New York, United States, 10016 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11040 | |
| Stony Brook University Cancer Center | |
| Stony Brook, New York, United States, 11794-8174 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Leo W. Jenkins Cancer Center at ECU Medical School | |
| Greenville, North Carolina, United States, 27835-6028 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Mission Hospitals - Memorial Campus | |
| Asheville, North Carolina, United States, 28801 | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| United States, North Dakota | |
| CCOP - MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Children's Hospital Medical Center of Akron | |
| Akron, Ohio, United States, 44308-1062 | |
| Children's Medical Center - Dayton | |
| Dayton, Ohio, United States, 45404-1815 | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195-5217 | |
| Medical University of Ohio Cancer Center | |
| Toledo, Ohio, United States, 43614 | |
| Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106-5000 | |
| Tod Children's Hospital - Forum Health | |
| Youngstown, Ohio, United States, 44501 | |
| United States, Oklahoma | |
| Oklahoma University Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Legacy Emanuel Hospital and Health Center & Children's Hospital | |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104-9786 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| St. Christopher's Hospital for Children | |
| Philadelphia, Pennsylvania, United States, 19134-1095 | |
| United States, Rhode Island | |
| Rhode Island Hospital Comprehensive Cancer Center | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Greenville Hospital System Cancer Center | |
| Greenville, South Carolina, United States, 29605 | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, South Dakota | |
| Sioux Valley Hospital and University of South Dakota Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Tennessee | |
| East Tennessee Children's Hospital | |
| Knoxville, Tennessee, United States, 37916 | |
| East Tennessee State University Cancer Center at Johnson City Medical Center | |
| Johnson City, Tennessee, United States, 37604 | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6310 | |
| United States, Texas | |
| Baylor University Medical Center - Houston | |
| Houston, Texas, United States, 77030-2399 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Children's Hospital of Austin | |
| Austin, Texas, United States, 78701 | |
| Methodist Children's Hospital of South Texas | |
| San Antonio, Texas, United States, 78229-3993 | |
| Covenant Children's Hospital | |
| Lubbock, Texas, United States, 79410 | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104-9958 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States, 75390 | |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | |
| Amarillo, Texas, United States, 79106 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78207 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | |
| Burlington, Vermont, United States, 05405 | |
| United States, Virginia | |
| Children's Hospital of The King's Daughters | |
| Norfolk, Virginia, United States, 23507-1971 | |
| INOVA Fairfax Hospital | |
| Fairfax, Virginia, United States, 22031 | |
| University of Virginia Cancer Center at UV Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| Virginia Commonwealth University Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| Mary Bridge Children's Hospital and Health Center - Tacoma | |
| Tacoma, Washington, United States, 98405 | |
| United States, West Virginia | |
| Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | |
| Huntington, West Virginia, United States, 25701 | |
| Mary Babb Randolph Cancer Center at West Virginia University Hospitals | |
| Morgantown, West Virginia, United States, 26506 | |
| United States, Wisconsin | |
| Marshfield Clinic - Marshfield Center | |
| Marshfield, Wisconsin, United States, 54449 | |
| Midwest Children's Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Australia, New South Wales | |
| Prince of Wales Private Hospital | |
| Randwick, New South Wales, Australia, 2031 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6001 | |
| Canada, Alberta | |
| Alberta Children's Hospital | |
| Calgary, Alberta, Canada, T3B 6A8 | |
| University of Alberta Hospital | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| Children's & Women's Hospital of British Columbia | |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Canada, Nova Scotia | |
| IWK Health Centre | |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Canada, Ontario | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 3N6 | |
| Children's Hospital of Eastern Ontario | |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| McMaster Children's Hospital at Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Canada, Quebec | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Montreal Children's Hospital at McGill University Health Center | |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre at Pasqua Hospital | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Saskatoon Cancer Centre at the University of Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Netherlands | |
| University Medical Center Groningen | |
| Groningen, Netherlands, 9713 EZ | |
| Puerto Rico | |
| San Jorge Children's Hospital | |
| Santurce, Puerto Rico, 00912 | |
| Study Chair: | Howard M. Katzenstein, MD | AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus |
More Information
| Study ID Numbers: | CDR0000067200, COG-P9645, POG-9645, CCG-P9645 |
| Study First Received: | November 1, 1999 |
| Last Updated: | October 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003994 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I childhood liver cancer recurrent childhood liver cancer childhood hepatoblastoma |
|
Antimetabolites Liver Diseases Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Liver Neoplasms Neoplasms by Site Cisplatin Therapeutic Uses Hepatoblastoma Neoplasms by Histologic Type |
Digestive System Neoplasms Mitosis Modulators Vincristine Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Fluorouracil Tubulin Modulators Antineoplastic Agents, Phytogenic Neoplasms, Complex and Mixed |
