Diagnostic Study of Patients With Stage I Testicular Cancer

Testicular Germ Cell Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003800
• Other study ID #: CDR0000066944
• Secondary ID: U10CA021115ECOG-
• Status: Completed
• Phase: N/A
• Start date: November 16, 1999

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 76
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 15 Years to 120 Years

Eligibility

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

• 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

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Procedure:
• radionuclide imaging

Locations

Country	Name	City	State
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois
United States	MetroHealth's Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	CCOP - Scott and White Hospital	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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