NCT03067181 · Children's Oncology Group
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Best Practice
Undergo observation
PROCEDURE
Biopsy Procedure
Undergo a tumor biopsy
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
BIOLOGICAL
Bleomycin Sulfate
Given IV
DRUG
Carboplatin
Given IV
DRUG
Cisplatin
Given IV
PROCEDURE
Computed Tomography
Undergo a CT scan
DRUG
Etoposide
Given IV
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
PROCEDURE
Pulmonary Function Test
Undergo a pulmonary function test
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
Overall survival
Time frame: Two years post enrollment
The time from study entry to the date of death, or date of last contact and ascertained as alive, whichever comes first.
Event-free survival
Time frame: Two years post enrollment
The time from study entry to the date of death, date of disease progression or recurrence, date of second malignant neoplasm or date of last contact and ascertained as alive, whichever comes first.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT \[all sites\])
- Standard risk 1: Patients must be \< 11 years of age at enrollment
- Standard risk 2: Patients must be \>= 11 and \< 25 years of age at enrollment
- Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with malignant germ cell tumor (stage II or higher).
- Histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment , with the following exceptions:
- Among patients were initially diagnosed with completely resected non-seminoma malignant GCT and later recur during observation post surgery, a diagnostic biopsy is not required for enrollment if elevated tumor markers rise to \> 5 x upper limit of normal (ULN) on at l
Where
- Birmingham, Alabama
- Mobile, Alabama
- Anchorage, Alaska
- Kingman, Arizona
- Mesa, Arizona
- Phoenix, Arizona
- Tucson, Arizona
- Hot Springs, Arkansas
- Little Rock, Arkansas
- Anaheim, California
- Arroyo Grande, California
- Bellflower, California
And 330 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations