Diagnostic Study of Patients With Stage I Testicular Cancer

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.

DISEASE CHARACTERISTICS:

- Clinical stage I nonseminomatous germ cell tumor of the testis

- Must have had a radical inguinal orchiectomy with or without retroperitoneal lymph
node dissection within prior 12 weeks

- AFP and HCG normal or decreasing after orchiectomy at a rate consistent with
known half lives

- Pathology blocks and radiologic studies available

- No metastatic disease on physical exam or chest or abdominal/pelvic CT

- No pure seminoma (unless associated with elevated AFP at diagnosis)

PATIENT CHARACTERISTICS:

Age:

- 15 and over

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No prior malignancy including prior primary testicular cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics