AGCT1531 (Children and Adults with Germ Cell Tumors)

What is the 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.

What is the Condition Being Studied?

Pediatric and Adult Patients with Germ Cell Tumors

Who Can Participate in the Study?

Female children and adults who:

  • Are aged 49 or younger
  • Have primary extracranial germ cell tumor
  • Have received prior systemic therapy
Age Group

What is Involved?

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

If you are in the low risk group, you will:

  • 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

If you are in 1 of the 2 standard risk groups, you will:

  • 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
Associate Professor of Pediatrics
Protocol Number
IRB: PRO00084265
NCT: NCT03067181
Phase III
Enrollment Status