Diagnostic Study of Patients With Stage I Testicular Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00003800
First received: November 1, 1999
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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 Intervention
Testicular Germ Cell Tumor
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: radionuclide imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology With Outcome in Early Stage Nonseminomatous Germ Cell Tumor

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Evidence of regional or metastatic spread [ Time Frame: observed at least annually ] [ Designated as safety issue: No ]
    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.


Enrollment: 76
Study Start Date: May 1999
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Laboratory/CT evaluation
Observation following orchiectomy
Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: radionuclide imaging

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003800

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611-4494
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, Ohio
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
CCOP - Columbus
Columbus, Ohio, United States, 43206
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-0001
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Richard S. Foster, MD Indiana University Melvin and Bren Simon Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00003800     History of Changes
Other Study ID Numbers: CDR0000066944, U10CA021115, ECOG-8897
Study First Received: November 1, 1999
Last Updated: November 30, 2012
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
stage I malignant testicular germ cell tumor
stage II malignant testicular germ cell tumor
testicular embryonal carcinoma
testicular choriocarcinoma
testicular teratoma
testicular yolk sac tumor
testicular embryonal carcinoma and teratoma
testicular embryonal carcinoma and yolk sac tumor
testicular yolk sac tumor and teratoma
testicular choriocarcinoma and yolk sac tumor
testicular choriocarcinoma and embryonal carcinoma
testicular choriocarcinoma and teratoma

Additional relevant MeSH terms:
Testicular Neoplasms
Neoplasms, Germ Cell and Embryonal
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 28, 2014