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Home > "C" Clinical Trials Conditions > CT Scans in Treating Patients With Stage I Testicular Cancer After Undergoing Orchiectomy  CT Scans in Treating Patients With Stage I Testicular Cancer After Undergoing Orchiectomy
CT Scans in Treating Patients With Stage I Testicular Cancer After Undergoing Orchiectomy
For Condition: stage 1 testicular cancer,testicular teratoma
Status: No longer recruiting
Sponsor(s): Medical Research Council ,
Synopsis: 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.
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:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GordonSampson Rustin, Study Chair, Mount Vernon Hospital
Mount Vernon Hospital
Northwood, England, HA6 2RN
United Kingdom
Additional Information:
Study ID Numbers: CDR0000066440; MRC-TE08,EU-98007,ISRCTN56475197
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003420
Other Stage 1 Testicular Cancer Studies:
1. CT Scans in Treating Patients With Stage I Testicular Cancer After Undergoing Orchiectomy
Related Studies:
Other stage 1 testicular cancer Clinical Trials
Other England Clinical Trials
Other Northwood Clinical Trials
CT Scans in Treating Patients With Stage I Testicular Cancer After Undergoing Orchiectomy
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