We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diagnostic Study of Patients With Stage I Testicular Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003800
First Posted: January 27, 2003
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
November 1, 1999
January 27, 2003
October 23, 2017
May 1999
December 2004   (Final data collection date for primary outcome measure)
Evidence of regional or metastatic spread [ Time Frame: 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.
Not Provided
Complete list of historical versions of study NCT00003800 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Diagnostic Study of Patients With Stage I Testicular Cancer
Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology With Outcome in Early Stage Nonseminomatous Germ Cell Tumor

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Testicular Germ Cell Tumor
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
  • Procedure: radionuclide imaging
No Intervention: Laboratory/CT evaluation
Observation following orchiectomy
Interventions:
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
  • Procedure: radionuclide imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
Not Provided
December 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
15 Years to 120 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003800
CDR0000066944
U10CA021115 ( U.S. NIH Grant/Contract )
ECOG-8897
No
Not Provided
Not Provided
Eastern Cooperative Oncology Group
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Richard S. Foster, MD Indiana University Melvin and Bren Simon Cancer Center
Eastern Cooperative Oncology Group
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP