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


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Testicular Cancer & Self Exam

 




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

This study is no longer recruiting patients.

Sponsored by: Medical Research Council
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention
stage I testicular cancer
testicular teratoma
 Procedure: computed tomography
 Procedure: diagnostic test

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Testicular Cancer

Study Type: Interventional
Study Design: Diagnostic

Official Title: Randomized Study of CT Scan Frequency in Patients with Stage I Testicular Teratoma After Orchidectomy

Further Study Details: 

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:  Both

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:

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Location Information


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

Study chairs or principal investigators

Gordon John Sampson Rustin, MD,  Study Chair,  Mount Vernon Hospital   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066440; MRC-TE08; EU-98007; ISRCTN56475197
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003420
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: December 9, 2005
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