Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Diagnostic Study of Patients With Stage I Testicular Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic	Closed	15 and over	NCI	ECOG-8897 E8897, NCT00003800

Objectives

1. 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.
2. Compare these findings with other predictive models of risk of metastasis after orchiectomy in this group of patients.

Entry Criteria

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)

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

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

Expected Enrollment

A total of 315 patients will be accrued for this study within 3 years.

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Richard Foster, MD, Protocol chair		Ph: 317-278-4822; 888-600-4822

Registry Information
Official Title		Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology with Outcome in Early Stage Nonseminomatous Germ Cell Tumor
Trial Start Date		1999-05-26
Registered in ClinicalTrials.gov		NCT00003800
Date Submitted to PDQ		1999-03-02
Information Last Verified		2001-06-04
NCI Grant/Contract Number		CA21115

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