Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00053352
First received: January 27, 2003
Last updated: August 3, 2012
Last verified: August 2011
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is effective in decreasing the recurrence of childhood germ cell tumors.
PURPOSE: This phase III trial is studying surgery followed by combination chemotherapy to see how well it works in treating children with germ cell tumors that are not located in the head.
| Condition | Intervention | Phase |
|---|---|---|
|
Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Ovarian Cancer |
Biological: bleomycin sulfate Drug: cisplatin Drug: etoposide Procedure: conventional surgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Event-free survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 306 |
| Study Start Date: | November 2003 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine whether children with newly diagnosed low- or intermediate-risk extracranial germ cell tumors (GCTs) can maintain a 3-year event-free survival of at least 92% (for intermediate-risk tumors only) and overall survival of at least 95% (both low-risk and intermediate-risk tumors) after treatment with surgery followed by compressed cisplatin, etoposide, and bleomycin(low-risk disease closed to accrual as of 01/20/10).
- Determine the percentage of patients with stage I ovarian or stage I testicular GCTs for whom chemotherapy can be eliminated.
- Determine the percentage of intermediate-risk patients who require only 3 courses of therapy.
- Determine the acute toxic effects of compressed therapy in these patients.
- Determine the long-term sequelae in patients treated with this regimen.
- Determine the number of hospital days and total drug doses required for patients treated with compressed therapy.
- Compare the number of protocol-directed treatment days used in CCG-8882 vs the number of treatment days used in this study.
- Determine the cytogenetic and molecular genetic features in patients treated with this regimen.
OUTLINE: Patients are stratified according to disease risk (low vs intermediate).
Surgery: Patients undergo surgical resection.
- Low-risk disease: Patients with gonadal primaries and no evidence of disease after surgery undergo monitoring for disease progression. Patients who remain disease free receive no further treatment. Patients who have disease progression after surgery receive compressed induction chemotherapy. (closed to accrual as of 01/20/2010)
- Intermediate-risk disease: After surgery, patients proceed to compressed induction chemotherapy.
- Compressed induction therapy: Patients receive cisplatin IV over 90 minutes and etoposide IV over 90 minutes on days 1-3 and bleomycin IV over ≥ 10 minutes on day 1. Treatment repeats every 3 weeks for 3 courses (weeks 0, 3, and 6).
After completion of compressed induction chemotherapy, patients who have no change in disease status or disease progression are removed from study. Patients with no evidence of disease receive no further therapy. Patients with a partial response or who have abnormal tumor markers proceed to second-look surgery and/or 3 more courses of compressed consolidation chemotherapy.
- Second-look surgery: Patients undergo surgical resection of residual tumor. After surgery, patients who are in pathologic complete response and have normal tumor markers receive no further therapy. Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy.
- Compressed consolidation chemotherapy: Patients receive cisplatin, etoposide, and bleomycin as in induction chemotherapy in weeks 10, 13, and 16.
Patients are followed up monthly for 6 months, every 3 months for 18 months, and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 306 patients (126 with low-risk disease and 180 with intermediate-risk disease) will be accrued for this study within 6 years.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Extracranial germ cell tumor that contains 1 of the following malignant histologies:
- Yolk sac tumor
- Embryonal carcinoma
- Choriocarcinoma
- NOTE: Mixed germ cell tumors that include mature/immature teratoma are eligible provided 1 of the 3 histologies listed above is also present in the tumor.
Low-risk disease (closed to accrual as of 01/20/10)
- Stage I gonadal tumors (ovarian and testicular)
- Must have undergone complete surgical and radiologic staging to exclude the possibility of > stage I disease
Intermediate-risk disease
- Stage II, III, or IV malignant testicular GCT
- Stage II or III malignant ovarian GCT
- Stage I or II malignant extragonadal GCT
- Previously stage I gonadal patients who have relapsed on the low-risk (observation) stratum of this study(closed to accrual as of 01/20/10)
- Patients with immature teratoma or mature teratoma who relapse with a malignant component
No patients with any of the following diagnoses:
- Stage IV ovarian and stage III-IV extragonadal GCT
- Intracranial GCT
- Pure mature or immature teratoma, pure dysgerminoma, or seminoma
- Patients with a non-germ cell component in their GCT (e.g., primitive neuroectodermal tumors or rhabdomyosarcoma)
Alpha-fetoprotein and beta human chorionic gonadotropin tumor markers known
- If > 5 days have elapsed from the time of obtaining original markers, tumor markers must be repeated before enrollment of low-risk patients and before initiating therapy in intermediate-risk patients (the results of the repeated tumor markers do not have to be known at the time of study enrollment)
- Must be enrolled within 6 weeks of original diagnostic surgery
PATIENT CHARACTERISTICS:
Age
- 21 and under at diagnosis (under 15 for patients with primary testicular tumors; if over 15, will be treated as adults)
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR a serum creatinine based on age/gender as follows:
- ≤ 0.4 mg/dL (for patients 1 to 5 months of age)
- ≤ 0.5 mg/dL (for patients 6 to 11 months of age)
- ≤ 0.6 mg/dL (for patients 1 year of age)
- ≤ 0.8 mg/dL (for patients 2 to 5 years of age)
- ≤ 1.0 mg/dL (for patients 6 to 9 years of age)
- ≤ 1.2 mg/dL (for patients 10 to 12 years of age)
- ≤ 1.4 mg/dL (for female patients ≥ 13 years of age)
- ≤ 1.5 mg/dL (for male patients 13 to 15 years of age)
- ≤ 1.7 mg/dL (for male patients ≥ 16 years of age)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy
Surgery
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053352
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Hide Study LocationsLocations
| United States, Alabama | |
| UAB Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| University of South Alabama Mitchell Cancer Institute | |
| Mobile, Alabama, United States, 36604 | |
| United States, Arizona | |
| 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 | |
| Southern California Permanente Medical Group | |
| Downey, California, United States, 90027 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | |
| Long Beach, California, United States, 90801 | |
| Childrens Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Children's Hospital Central California | |
| Madera, California, United States, 93638-8762 | |
| Children's Hospital and Research Center Oakland | |
| Oakland, California, United States, 94609 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| Lucile Packard Children's Hospital at Stanford University Medical Center | |
| Palo Alto, California, United States, 95798 | |
| Kaiser Permanente Medical Center - Oakland | |
| Sacramento, California, United States, 95825 | |
| Sutter Cancer Center | |
| Sacramento, California, United States, 95816 | |
| Rady Children's Hospital - San Diego | |
| San Diego, California, United States, 92123-4282 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Colorado | |
| Children's Hospital Center for Cancer and Blood Disorders | |
| Aurora, Colorado, United States, 80045 | |
| Presbyterian - St. Luke's Medical Center | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| Connecticut Children's Medical Center | |
| Hartford, Connecticut, United States, 06106 | |
| Yale Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | |
| Wilmington, Delaware, United States, 19803 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5001 | |
| United States, Florida | |
| Broward General Medical Center Cancer Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Lee Cancer Care of Lee Memorial Health System | |
| Fort Myers, Florida, United States, 33901 | |
| University of Florida Shands Cancer Center | |
| Gainesville, Florida, United States, 32610-0232 | |
| Memorial Cancer Institute at Memorial Regional Hospital | |
| Hollywood, Florida, United States, 33021 | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | |
| Miami, Florida, United States, 33136 | |
| 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 | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | |
| Orlando, Florida, United States, 32803-1273 | |
| Nemours Children's Clinic - Pensacola | |
| Pensacola, Florida, United States, 32504 | |
| All Children's Hospital | |
| Saint Petersburg, Florida, United States, 33701 | |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | |
| Tampa, Florida, United States, 33607 | |
| Kaplan Cancer Center at St. Mary's Medical Center | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | |
| Atlanta, Georgia, United States, 30322 | |
| MBCCOP - Medical College of Georgia Cancer Center | |
| Augusta, Georgia, United States, 30912-3730 | |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | |
| Savannah, Georgia, United States, 31403-3089 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Idaho | |
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | |
| Boise, Idaho, United States, 83712-6297 | |
| United States, Illinois | |
| Children's Memorial Hospital - Chicago | |
| Chicago, Illinois, United States, 60614 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Keyser Family Cancer Center at Advocate Hope Children's Hospital | |
| Oak Lawn, Illinois, United States, 60453 | |
| Advocate Lutheran General Cancer Care Center | |
| Park Ridge, Illinois, United States, 60068-1174 | |
| Saint Jude Midwest Affiliate | |
| Peoria, Illinois, United States, 61637 | |
| Simmons Cooper Cancer Institute | |
| Springfield, Illinois, United States, 62794-9677 | |
| United States, Indiana | |
| St. Vincent Indianapolis Hospital | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kentucky | |
| Lucille P. Markey Cancer Center at University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0093 | |
| Kosair Children's Hospital | |
| Louisville, Kentucky, United States, 40232 | |
| United States, Maryland | |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | |
| Baltimore, Maryland, United States, 21215 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | |
| Springfield, Massachusetts, United States, 01199-0001 | |
| United States, Michigan | |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | |
| Ann Arbor, Michigan, United States, 48109-0286 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Helen DeVos Children's Hospital at Spectrum Health | |
| Grand Rapids, Michigan, United States, 49503 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-5381 | |
| Breslin Cancer Center at Ingham Regional Medical Center | |
| Lansing, Michigan, United States, 48910 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805-1983 | |
| Masonic Cancer Center at University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | |
| Minneapolis, Minnesota, United States, 55404 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Children's Hospitals and Clinics of Minnesota - St. Paul | |
| St. Paul, Minnesota, United States, 55102-2392 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Cardinal Glennon Children's Hospital | |
| St. Louis, Missouri, United States, 63104 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | |
| 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 | |
| Hackensack University Medical Center Cancer Center | |
| Hackensack, New Jersey, United States, 07601 | |
| Overlook Hospital | |
| Morristown, New Jersey, United States, 07962 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Saint Peter's University Hospital | |
| New Brunswick, New Jersey, United States, 08901 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| St. Joseph's Hospital and Medical Center | |
| Paterson, New Jersey, United States, 07503 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| United States, New York | |
| Albany Medical Center Hospital | |
| Albany, New York, United States, 12208-3419 | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| Brooklyn Hospital Center | |
| Brooklyn, New York, United States, 11201-5493 | |
| Maimonides Cancer Center at Maimonides Medical Center | |
| Brooklyn, New York, United States, 11219 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11040 | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| 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 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| Mission Hospitals - Memorial Campus | |
| Asheville, North Carolina, United States, 28801 | |
| Presbyterian Cancer Center at Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| 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 | |
| Akron Children's Hospital | |
| Akron, Ohio, United States, 44308-1062 | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106-5000 | |
| Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205-2696 | |
| Dayton Children's - Dayton | |
| Dayton, Ohio, United States, 45404-1815 | |
| Mercy Children's Hospital | |
| Toledo, Ohio, United States, 43608 | |
| Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| Tod Children's Hospital | |
| Youngstown, Ohio, United States, 44501 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital - Muhlenberg | |
| Bethlehem, Pennsylvania, United States, 18017 | |
| Geisinger Cancer Institute at Geisinger Health | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Penn State Children's Hospital | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| St. Christopher's Hospital for Children | |
| Philadelphia, Pennsylvania, United States, 19134-1095 | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104-9786 | |
| Children's Hospital of Pittsburgh of UPMC | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Palmetto Health South Carolina Cancer Center | |
| Columbia, South Carolina, United States, 29203 | |
| Greenville Hospital Cancer Center | |
| Greenville, South Carolina, United States, 29605 | |
| United States, South Dakota | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sanford Cancer Center at Sanford USD Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Tennessee | |
| T.C. Thompson Children's Hospital | |
| Chattanooga, Tennessee, United States, 37403 | |
| East Tennessee State University Cancer Center at Johnson City Medical Center | |
| Johnson City, Tennessee, United States, 37604 | |
| East Tennessee Children's Hospital | |
| Knoxville, Tennessee, United States, 37901 | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | |
| Amarillo, Texas, United States, 79106 | |
| Dell Children's Medical Center of Central Texas | |
| Austin, Texas, United States, 78723 | |
| Driscoll Children's Hospital | |
| Corpus Christi, Texas, United States, 78411 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States, 75390 | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104 | |
| Baylor University Medical Center - Houston | |
| Houston, Texas, United States, 77030-2399 | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Covenant Children's Hospital | |
| Lubbock, Texas, United States, 79410 | |
| Methodist Children's Hospital of South Texas | |
| San Antonio, Texas, United States, 78229-3993 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78207 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| Primary Children's Medical Center | |
| Salt Lake City, Utah, United States, 84113-1100 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Inova Fairfax Hospital | |
| Falls Church, Virginia, United States, 22042-3300 | |
| Children's Hospital of The King's Daughters | |
| Norfolk, Virginia, United States, 23507-1971 | |
| Naval Medical Center - Portsmouth | |
| Portsmouth, Virginia, United States, 23708-2197 | |
| Carilion Medical Center for Children at Roanoke Community Hospital | |
| Roanoke, Virginia, United States, 24014 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| Deaconess Medical Center | |
| Spokane, Washington, United States, 99210-0248 | |
| Providence Cancer Center at Sacred Heart Medical Center | |
| Spokane, Washington, United States, 99220-2555 | |
| Madigan Army Medical Center - Tacoma | |
| Tacoma, Washington, United States, 98431 | |
| United States, West Virginia | |
| West Virginia University Health Sciences Center - Charleston | |
| Charleston, West Virginia, United States, 25302 | |
| United States, Wisconsin | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Gundersen Lutheran Center for Cancer and Blood | |
| La Crosse, Wisconsin, United States, 54601 | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Marshfield Clinic - Marshfield Center | |
| Marshfield, Wisconsin, United States, 54449 | |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Australia, New South Wales | |
| Sydney Children's Hospital | |
| Randwick, New South Wales, Australia, 2031 | |
| Children's Hospital at Westmead | |
| Westmead, New South Wales, Australia, 2145 | |
| 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, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Newfoundland and Labrador | |
| Janeway Children's Health and Rehabilitation Centre | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| IWK Health Centre | |
| Halifax, Nova Scotia, Canada, B3J 3G9 | |
| Canada, Ontario | |
| McMaster Children's Hospital at Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Children's Hospital of Eastern Ontario | |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Canada, Quebec | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| 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 | |
| Canada | |
| Centre Hospitalier Universitaire de Quebec | |
| Quebec, Canada, G1V 4G2 | |
| New Zealand | |
| Starship Children's Health | |
| Auckland, New Zealand, 1 | |
| Puerto Rico | |
| San Jorge Children's Hospital | |
| Santurce, Puerto Rico, 00912 | |
| Switzerland | |
| Swiss Pediatric Oncology Group Bern | |
| Bern, Switzerland, 3010 | |
| Swiss Pediatric Oncology Group Geneva | |
| Geneva, Switzerland, 1205 | |
Sponsors and Collaborators
Children's Oncology Group
Investigators
| Study Chair: | A. Lindsay Frazier, MD, ScM | Dana-Farber Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gregory H. Reaman, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT00053352 History of Changes |
| Other Study ID Numbers: | CDR0000269433, COG-AGCT0132 |
| Study First Received: | January 27, 2003 |
| Last Updated: | August 3, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
childhood malignant ovarian germ cell tumor childhood extragonadal germ cell tumor childhood malignant testicular germ cell tumor childhood extracranial germ cell tumor childhood teratoma |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Neoplasms, Germ Cell and Embryonal Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Neoplasms by Histologic Type Bleomycin Cisplatin Etoposide Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013