Trial Information

Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology With Outcome in Early Stage Nonseminomatous Germ Cell Tumor

OBJECTIVES:

- Use histopathological and immunohistological analysis of the primary testis tumor along
with quantitative radiographic assessment to identify a subset of patients with
clinical stage I nonseminomatous germ cell tumor of the testis who have a very low risk
of metastasis.

- Compare these findings with other predictive models of risk of metastasis after
orchiectomy in this group of patients.

OUTLINE: Patients undergo primary retroperitoneal lymph node dissection (RPLND) or active
surveillance as management of their disease. The choice of treatment is determined by the
physician and the patient. Patients with pathologically positive resected lymph nodes may
undergo treatment (observation or adjuvant chemotherapy) at investigator's discretion.

All patients are tested by quantitative radiology and blood markers (HCG and AFP) at
baseline and then at various times after surgery to identify pathologic stage II disease.
The timing of these studies depends on the stage of disease and/or type of disease
management.

Patients who undergo RPLND, have stage I or II disease, and do not receive adjuvant therapy
(radiation or chemotherapy) are followed monthly during year 1, every 2 months during year
2, every 6 months during years 3-5, and annually thereafter.

Patients who undergo RPLND, have stage II disease, and receive adjuvant therapy are followed
every 2 months during year 1, every 4 months during year 2, every 6 months during years 3-5,
and annually thereafter.

Patients who do not undergo RPLND are followed monthly during year 1, every other month
during year 2, every 6 months during years 3-5, and annually thereafter.

PROJECTED ACCRUAL: A total of 315 patients will be accrued for this study within 3 years.