Diagnostic Study of Patients With Stage I Testicular Cancer

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.

Official Title

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

Conditions

• Testicular Germ Cell Tumour

Study Type

Interventional

Study Design

Diagnostic.

Further Details

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.

Study Start

May 1999

Eligibility & Criteria

• Ages Eligible for Study: 15 years and older
• Genders Eligible for Study: Male
• Accepts Healthy Volunteers: No

Clinical stage I nonseminomatous germ cell tumour 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

No prior chemotherapy Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

Total Enrolment

315

Contact Details

Richard S. Foster, MD
Indiana University Melvin and Bren Simon Cancer Center

Location:

Robert H. Lurie Comprehensive Cancer Center at Northwestern University    
Chicago, Illinois
United States, 60611