Diagnostic Study of Patients With Stage I Testicular Cancer

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003800

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

6.3

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Testicular Germ Cell Tumor	Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: radionuclide imaging	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

May 1, 1999

Actual Primary Completion Date :

Dec 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Laboratory/CT evaluation Observation following orchiectomy	Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: radionuclide imaging

Arm

Intervention/Treatment

No Intervention: Laboratory/CT evaluation

Observation following orchiectomy

Other: immunohistochemistry staining method

Other: laboratory biomarker analysis

Procedure: radionuclide imaging

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 120 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois	United States	60611-4494
2	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611
3	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
4	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
5	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
6	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
7	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
8	MetroHealth's Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio	United States	44109
9	CCOP - Columbus	Columbus	Ohio	United States	43206
10	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111-2497
11	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
12	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-0001