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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003800 |
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.
Condition | Intervention |
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Testicular Germ Cell Tumor |
Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: radionuclide imaging |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology With Outcome in Early Stage Nonseminomatous Germ Cell Tumor |
Estimated Enrollment: | 315 |
Study Start Date: | May 1999 |
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.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have had a radical inguinal orchiectomy with or without retroperitoneal lymph node dissection within prior 12 weeks
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
Chicago, Illinois, United States, 60611 | |
Veterans Affairs Medical Center - Lakeside Chicago | |
Chicago, Illinois, United States, 60611-4494 | |
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202-5289 | |
United States, Iowa | |
CCOP - Cedar Rapids Oncology Project | |
Cedar Rapids, Iowa, United States, 52403-1206 | |
United States, Michigan | |
CCOP - Kalamazoo | |
Kalamazoo, Michigan, United States, 49007-3731 | |
West Michigan Cancer Center | |
Kalamazoo, Michigan, United States, 49007 | |
United States, Nevada | |
CCOP - Southern Nevada Cancer Research Foundation | |
Las Vegas, Nevada, United States, 89106 | |
United States, Ohio | |
CCOP - Columbus | |
Columbus, Ohio, United States, 43206 | |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | |
Cleveland, Ohio, United States, 44109 | |
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111-2497 | |
United States, Texas | |
CCOP - Scott and White Hospital | |
Temple, Texas, United States, 76508 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-0001 |
Study Chair: | Richard S. Foster, MD | Indiana University Melvin and Bren Simon Cancer Center |
Study ID Numbers: | CDR0000066944, ECOG-8897 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003800 |
Health Authority: | United States: Federal Government |
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 |
Neoplasms, Germ Cell and Embryonal Choriocarcinoma Testicular cancer Nonseminomatous germ cell tumor |
Testicular Neoplasms Teratoma Carcinoma |
Neoplasms Neoplasms by Histologic Type |