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NCT00003420 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
NA
Status at capture
COMPLETED
Registry last update
2013-12-04

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
sex
MALE
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    computed tomography
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
primary Purpose
DIAGNOSTIC
Enrollment
count
900
type
ESTIMATED
Registered outcome plans (not posted results)
Full 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.
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.
Source references
references
  1. citation
    Rustin GJ, Mead GM, Stenning SP, Vasey PA, Aass N, Huddart RA, Sokal MP, Joffe JK, Harland SJ, Kirk SJ; National Cancer Research Institute Testis Cancer Clinical Studies Group. Randomized trial of two or five computed tomography scans in the surveillance of patients with stage I nonseminomatous germ cell tumors of the testis: Medical Research Council Trial TE08, ISRCTN56475197--the National Cancer Research Institute Testis Cancer Clinical Studies Group. J Clin Oncol. 2007 Apr 10;25(11):1310-5. doi: 10.1200/JCO.2006.08.4889.
    pmid
    17416851
    type
    RESULT
  2. citation
    Mead GM, Rustin GJ, Stenning SP, et al.: Medical Research Council trial of 2 versus 5 CT scans in the surveillance of patients with stage I non-seminomatous germ cell tumours of the testis. [Abstract] J Clin Oncol 24 (Suppl 18): A-4519, 221s, 2006.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        vic CT scans, but the preferred frequency of such scans is controversial.</p><p id="_662" tabindex="-1">A randomized controlled trial (<a href="/clinicaltrials/NCT00003420">MRC-TE08</a> [NCT00003420]) compared a schedule that used only two scans at 3 months and 12 months with a schedule that used five scans at 3, 6, 9, 12, and 24
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        rred frequency of such scans is controversial.</p><p id="_662" tabindex="-1">A randomized controlled trial (<a href="/clinicaltrials/NCT00003420">MRC-TE08</a> [NCT00003420]) compared a schedule that used only two scans at 3 months and 12 months with a schedule that used five scans at 3, 6, 9, 12, and 24 months.[<a href="#cit/sect
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      source title
      Testicular Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 16, 2025
        datetime
        2025-05-16T12:00:00Z
        display
        May 16, 2025

    Preserved source evidence · Not medical advice