Purpose of this Study
We are doing this study to find out if carefully watching patients with low risk germ cell tumors after surgery will have different results than treating people with chemotherapy afer their surgery.
For people who are in standard risk groups related to germ cell tumors, we want to compare the effects of carboplatin with cisplatin and find out which of these drugs seems to work better.
Who Can Participate?
Eligibility
Female children and adults who:
- Are aged 49 or younger
- Have primary extracranial germ cell tumor
- Have received prior systemic therapy
What is Involved?
Description
If you choose to join this study, you will be assigned to one of the following groups:
- Low risk
- Standard risk 1
- Standard risk 2
- Be closely watched for 2 years, and then less frequently watched for years 3-5
- Get blood tests and imaging tests to see if your tumor has came back
- Get a random assignment (like the flip of a coin) to get chemotherapy with bleomycin and etoposide that is combined with either cisplatin (standard) or carboplatin (experimental for this study)
- Take the assigned study regimen for either 3 or 4 drug cycles that last 3 weeks (21 days) each
- Have tissue and scans from your tumor tested
Study Details
Full Title
AGCT1531 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
Principal Investigator
Jessica
Sun
Protocol Number
PRO00084265
NCT ID
NCT03067181
Phase
III
Enrollment Status
Open to Enrollment