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Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
Sponsor: Children's Oncology Group
Summary
This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.
Official title: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
1780
Start Date
2017-05-25
Completion Date
2027-06-30
Last Updated
2026-08-25
Healthy Volunteers
No
Conditions
Interventions
Best Practice
Undergo observation
Biopsy Procedure
Undergo a tumor biopsy
Biospecimen Collection
Undergo blood sample collection
Bleomycin Sulfate
Given IV
Carboplatin
Given IV
Cisplatin
Given IV
Computed Tomography
Undergo a CT scan
Etoposide
Given IV
Magnetic Resonance Imaging
Undergo MRI
Pulmonary Function Test
Undergo a pulmonary function test
Questionnaire Administration
Ancillary studies
Locations (629)
Children's Hospital of Alabama
Birmingham, Alabama, United States
USA Health Strada Patient Care Center
Mobile, Alabama, United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Kingman Regional Medical Center
Kingman, Arizona, United States
Banner Children's at Desert
Mesa, Arizona, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
CARTI Cancer Center
Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Kaiser Permanente-Anaheim
Anaheim, California, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States
PCR Oncology
Arroyo Grande, California, United States
Kaiser Permanente-Bellflower
Bellflower, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Mercy Cancer Center - Carmichael
Carmichael, California, United States
Mercy San Juan Medical Center
Carmichael, California, United States
Kaiser Permanente Downey Medical Center
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Mercy Cancer Center - Elk Grove
Elk Grove, California, United States
Kaiser Permanente-Fontana
Fontana, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Mattel Children's Hospital UCLA
Los Angeles, California, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Providence Queen of The Valley
Napa, California, United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Mercy Cancer Center - Rocklin
Rocklin, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
Mercy Cancer Center - Sacramento
Sacramento, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Kaiser Permanente-San Diego Mission
San Diego, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
Naval Medical Center -San Diego
San Diego, California, United States
UCSF Medical Center-Mission Bay
San Francisco, California, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, United States
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, United States
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Woodland Memorial Hospital
Woodland, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States
Memorial Hospital North
Colorado Springs, Colorado, United States
Saint Francis Cancer Center
Colorado Springs, Colorado, United States
AdventHealth Porter
Denver, Colorado, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States
CommonSpirit Cancer Center Mercy
Durango, Colorado, United States
Mercy Medical Center
Durango, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States
Mountain Blue Cancer Care Center
Golden, Colorado, United States
UCHealth Greeley Hospital
Greeley, Colorado, United States
CommonSpirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States
AdventHealth Littleton
Littleton, Colorado, United States
UCHealth Lone Tree Health Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
AdventHealth Parker
Parker, Colorado, United States
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States
Kaiser Permanente-Capitol Hill Medical Center
Washington D.C., District of Columbia, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States