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


N/A
15 Years
N/A
Open (Enrolling)
Male
Testicular Germ Cell Tumor

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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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Evidence of regional or metastatic spread

Outcome Description:

Patients with putative stage A non-seminomatous germ cell tumors are assessed at baseline using chest xray and blood markers. They are then followed monthly during year 1, every 2 months during year 2, twice a year during years 3-5, and annually thereafter.

Outcome Time Frame:

observed at least annually

Safety Issue:

No

Principal Investigator

Richard S. Foster, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066944

NCT ID:

NCT00003800

Start Date:

May 1999

Completion Date:

Related Keywords:

  • Testicular Germ Cell Tumor
  • stage I malignant testicular germ cell tumor
  • stage II malignant testicular germ cell tumor
  • testicular embryonal carcinoma
  • testicular choriocarcinoma
  • testicular teratoma
  • testicular yolk sac tumor
  • testicular embryonal carcinoma and teratoma
  • testicular embryonal carcinoma and yolk sac tumor
  • testicular yolk sac tumor and teratoma
  • testicular choriocarcinoma and yolk sac tumor
  • testicular choriocarcinoma and embryonal carcinoma
  • testicular choriocarcinoma and teratoma
  • Testicular Neoplasms
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - KalamazooKalamazoo, Michigan  49007-3731
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - ColumbusColumbus, Ohio  43206
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
CCOP - Scott and White HospitalTemple, Texas  76508
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611