CT Scans in Treating Patients With Stage I Testicular Cancer After Undergoing Orchiectomy
NCT ID: NCT00003420
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
900 participants
INTERVENTIONAL
1997-07-31
2010-04-30
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
DIAGNOSTIC
Interventions
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computed tomography
Eligibility Criteria
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Inclusion Criteria
* 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
MALE
No
Sponsors
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Medical Research Council
OTHER_GOV
Principal Investigators
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Gordon J.S. Rustin, MD
Role: STUDY_CHAIR
Mount Vernon Cancer Centre at Mount Vernon Hospital
Locations
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Mount Vernon Hospital
Northwood, England, United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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MRC-TE08
Identifier Type: -
Identifier Source: secondary_id
EU-98007
Identifier Type: -
Identifier Source: secondary_id
ISRCTN56475197
Identifier Type: -
Identifier Source: secondary_id
CDR0000066440
Identifier Type: -
Identifier Source: org_study_id