Diagnostic Study of Patients With Stage I Testicular Cancer
- Conditions
- Testicular Germ Cell Tumor
- Interventions
- Other: immunohistochemistry staining methodOther: laboratory biomarker analysisProcedure: radionuclide imaging
- Registration Number
- NCT00003800
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Laboratory/CT evaluation laboratory biomarker analysis Observation following orchiectomy Laboratory/CT evaluation radionuclide imaging Observation following orchiectomy Laboratory/CT evaluation immunohistochemistry staining method Observation following orchiectomy
- Primary Outcome Measures
Name Time Method Evidence of regional or metastatic spread observed at least annually 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Veterans Affairs Medical Center - Lakeside Chicago
🇺🇸Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States