Study of Cisplatin-Induced Peripheral Neuropathy in Patients With Germ Cell Tumor

Primary Objective:

To describe the incidence and characteristics of, and change in, chronic neuropathy symptoms
related to cisplatin, using the EORTC CIPN-20 instrument

Procedures:

The EORTC QLQ-CIPN20 questionnaire will be completed on day one of each cycle of
chemotherapy, once every three weeks (+/-7 days) and once every 2 months (+/- 30 days) from
the last dose of chemotherapy. Patients will be asked to complete the questionnaire in clinic
during their routine visits.

As part of this study, a DNA blood sample will be collected and stored with the Indiana
Biobank on Day 1 of Cycle 1.

Inclusion criteria:

1. 15 years of age or older at the time of informed consent

2. Have a confirmed pathologic and/or by tumor marker diagnosis of testicular or
extragonadal germ cell cancer.

3. Provide written informed consent and assent (if applicable).

4. Ability to complete questionnaire(s) in English by themselves or with assistance.

5. Willing to provide a 10 mL blood sample for future DNA testing

6. Planning to receive at least 3 cycles of cisplatin (20 mg/m2/d for 5 days) based
chemotherapy.

7. Must agree to continued clinical follow-up at the study cancer center.

Exclusion criteria:

1. Diagnosis (current or previous) of peripheral neuropathy (from diabetes or other
causes).

2. Previous exposure to neurotoxic chemotherapy drugs including taxanes, platinum agents,
vinca alkaloids, or epothilones.

3. Salvage chemotherapy treatment or bone marrow transplant. Salvage chemotherapy is
defined as any treatment after relapse of the disease following initial chemotherapy
treatment.