Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U10CA021115 | U.S. NIH Grant/Contract | View source | |
| ECOG-8897 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Diagnostic procedures may improve a doctor's ability to predict the recurrence of testicular cancer.
PURPOSE: Diagnostic trial to detect the risk of recurrent disease in patients who have stage I testicular cancer and who have undergone orchiectomy within the previous 12 weeks.
OBJECTIVES:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laboratory/CT evaluation | No Intervention | Observation following orchiectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunohistochemistry staining method | Other |
| ||
| laboratory biomarker analysis |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
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
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard S. Foster, MD | Indiana University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center - Lakeside Chicago | Chicago | Illinois | 60611-4494 | United States | ||
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
| radionuclide imaging | Procedure |
|
| Chicago |
| Illinois |
| 60611 |
| United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa | 52403-1206 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792-0001 | United States |
| ID | Term |
|---|---|
| C563236 | Testicular Germ Cell Tumor |
| D013736 | Testicular Neoplasms |
| C562472 | Teratoma, Testicular |
| D018240 | Endodermal Sinus Tumor |
| D013724 | Teratoma |
| D018236 | Carcinoma, Embryonal |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D008649 | Mesonephroma |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D007150 | Immunohistochemistry |
| ID | Term |
|---|---|
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
Not provided
Not provided