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CT Scans in Treating Patients With Stage I Testicular Cancer After Undergoing Orchiectomy

Sponsor
Medical Research Council (Other)
Overall Status
Completed
CT.gov ID
NCT00003420
Collaborator
(none)
900
Enrollment
1
Location
153
Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: computed tomography
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Randomized
Primary Purpose:
Diagnostic
Official Title:
A Study of CT Scan Frequency in Patients With Stage I Testicular Teratoma
Study Start Date :
Jul 1, 1997
Actual Study Completion Date :
Apr 1, 2010

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00003420
    Other Study ID Numbers:
    • CDR0000066440
    • MRC-TE08
    • EU-98007
    • ISRCTN56475197
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Dec 4, 2013
    Last Verified:
    Dec 1, 2002
    Keywords provided by , ,
    stage I malignant testicular germ cell tumor
    testicular teratoma
    Additional relevant MeSH terms:
    Neoplasms, Germ Cell and Embryonal

    Study Results

    No Results Posted as of Dec 4, 2013