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

Primary Purpose

Testicular Germ Cell Tumor

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
computed tomography
Sponsored by
Medical Research Council
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Testicular Germ Cell Tumor focused on measuring stage I malignant testicular germ cell tumor, testicular teratoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Vernon Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 3, 2013
Sponsor
Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT00003420
Brief Title
CT Scans in Treating Patients With Stage I Testicular Cancer After Undergoing Orchiectomy
Official Title
A Study of CT Scan Frequency in Patients With Stage I Testicular Teratoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2002
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical Research Council

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Testicular Germ Cell Tumor
Keywords
stage I malignant testicular germ cell tumor, testicular teratoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
computed tomography

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon J.S. Rustin, MD
Organizational Affiliation
Mount Vernon Cancer Centre at Mount Vernon Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17416851
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.
Results Reference
result
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.
Results Reference
result

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

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