ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
CT Scans in Treating Patients With Stage I Testicular Cancer After Undergoing Orchiectomy

This study is ongoing, but not recruiting participants.

Sponsored by: Medical Research Council
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003420
  Purpose

RATIONALE: Imaging procedures such as CT scans help the doctor in detecting cancer or the recurrence of cancer. Increasing the number of times a CT scan is given may improve the ability to detect stage I testicular cancer.

PURPOSE: Randomized clinical trial to determine if there is a different result from two different schedules of CT scans in treating patients with stage I testicular cancer after undergoing orchiectomy.


Condition Intervention
Testicular Germ Cell Tumor
Procedure: computed tomography

MedlinePlus related topics:   CT Scans    Cancer    Nuclear Scans    Testicular Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Randomized, Active Control
Official Title:   A Study of CT Scan Frequency in Patients With Stage I Testicular Teratoma

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   900
Study Start Date:   July 1997

Detailed Description:

OBJECTIVES:

  • Determine whether there is a difference between two schedules of CT scan surveillance in respect to stage of disease at relapse, survival, the investigation determining relapse, and incidence of second malignancies in patients with stage I testicular teratoma after orchidectomy.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and presence of vascular invasion.

After orchidectomy, patients are randomized into two schedules (arms I and II) of CT scan follow up.

  • Arm I: Patients repeat chest and abdominal CT scans no later than 3 months after orchidectomy and again at 12 months to confirm that the patient is clear of disease.
  • Arm II: Patients repeat chest and abdominal CT scans at 3, 6, 9, 12, and 24 months after orchidectomy.

Patients are followed monthly for the first year after orchidectomy, then every 2 months for the second year, then every 3 months for the third year, and then every 4-6 months thereafter.

PROJECTED ACCRUAL: There will be 400-900 patients accrued into this study over 3-6 years.

  Eligibility
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed nonseminomatous germ cell tumor of the testis Stage I disease:

    • No evidence of metastatic disease on clinical examination
    • Normal chest x-ray
    • Normal chest and abdominal CT scan
    • Normal serum tumor marker (AFP, HCG) after orchidectomy
  • High risk patients should be considered for ongoing studies of adjuvant chemotherapy after orchidectomy, but those choosing not to take this option may enter this study
  • Orchidectomy no greater than 8 weeks prior to randomization into this study

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other concurrent or prior malignancy except successfully treated nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003420

Locations
United Kingdom, England
Mount Vernon Hospital    
      Northwood, England, United Kingdom, HA6 2RN

Sponsors and Collaborators
Medical Research Council

Investigators
Study Chair:     Gordon J.S. Rustin, MD     Mount Vernon Cancer Centre at Mount Vernon Hospital    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000066440, MRC-TE08, EU-98007, ISRCTN56475197
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003420
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I malignant testicular germ cell tumor  
testicular teratoma  

Study placed in the following topic categories:
Neoplasms, Germ Cell and Embryonal
Testicular cancer
Testicular Neoplasms
Teratoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 21, 2008




Links to all studies - primarily for crawlers