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AGCT1531 for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if we keep an eye on patients with low risk germ cell tumors after your tumor is removed, will it work like following surgery with chemotherapy and/or more surgery.

For the standard risk groups 1 and 2, we want to compare the effects of carboplatin with cisplatin for patients with standard risk germ cell tumors to find out which one is 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
Adults, Children

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 or standard risk 2

If you are in:
- Low risk group:
-- Be closely watched for 2 years and less frequently for years 3-5
-- Get blood tests and imaging tests to see if your tumor has came back

- Standard risk 1 and 2 groups:
-- Be put into one of two groups (Like the flip of a coin) to get chemotherapy with bleomycin, etoposide and either cisplatin (standard) or carboplatin (experimental).
-- Get one of the two treatments for either 3 or 4 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
Pediatric Hematology-Oncology Specialist
Protocol Number
IRB:PRO00084265
NCT:NCT03067181
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698