A Phase III Study Evaluating Less Intensive Ways to Treat Germ Cell Tumors

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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 (CIRB)

Purpose

Germ cell tumors (GCTs) include ovarian teratomas and testicular cancers. The standard treatment for “low-risk” GCTs includes complete removal by surgery followed by chemotherapy with cisplatin, bleomycin, and etoposide, unless the patient is a young child, in which case careful observation may be adequate. GCTs are considered “standard risk” if the patient is under age 25 at diagnosis, the tumor was not completely removed during surgery or has spread to other parts of the body, or proteins in the blood called tumor markers are elevated. The standard treatment for standard-risk GCTs includes chemotherapy with cisplatin, bleomycin, and etoposide followed by surgery, followed by more chemotherapy if needed.

Chemotherapy, however, has side effects. Cisplatin has been known to cause long-term side effects such as hearing loss and damage to the kidneys. In this study, researchers are evaluating less intensive ways to treat GCTs and want to know if they are as effective as the standard treatments. Patients under age 50 with low-risk GCTs will not automatically receive chemotherapy after surgery; instead, they will be monitored and only receive chemotherapy or further surgery if the tumor comes back or spreads.

For the patients under age 25 with standard-risk GCTs, researchers want to see if giving the drug carboplatin instead of cisplatin is as effective and causes fewer side effects than cisplatin. Patients with standard-risk GCTs will be randomly assigned to receive either cisplatin, bleomycin, and etoposide or carboplatin, bleomycin, and etoposide. These drugs are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a low-risk or standard-risk GCT and be under age 50.
  • Patients may not have had prior systemic therapy (chemotherapy).
  • In addition to patients with good physical function, this study is also open to those who are capable of only limited self-care and are confined to bed or chair for more than half of their normal waking hours.

For more information about this study and to inquire about eligibility, please call 212-639-6729.

Protocol

19-089

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator