Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology With Outcome in Early Stage Nonseminomatous Germ Cell Tumor
- 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
- 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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Evidence of regional or metastatic spread
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.
observed at least annually
Richard S. Foster, MD
Indiana University Melvin and Bren Simon Cancer Center
United States: Federal Government
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|CCOP - Southern Nevada Cancer Research Foundation||Las Vegas, Nevada 89106|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|CCOP - Columbus||Columbus, Ohio 43206|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|MetroHealth's Cancer Care Center at MetroHealth Medical Center||Cleveland, Ohio 44106|
|CCOP - Scott and White Hospital||Temple, Texas 76508|
|Veterans Affairs Medical Center - Lakeside Chicago||Chicago, Illinois 60611|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|