Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic	Closed	Not specified	Other	MRC-TE08 EU-98007, ISRCTN56475197, NCT00003420

Objectives

1. 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.

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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

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

Expected Enrollment

There will be 400-900 patients accrued into this study over 3-6 years.

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.

Rustin GJ, Mead GM, Stenning SP, et al.: 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 25 (11): 1310-5, 2007.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Gordon Rustin, MD, Protocol chair		Ph: 44-1923-844-389 Email: grustin@nhs.net

Registry Information
Official Title		A Study of CT Scan Frequency in Patients With Stage I Testicular Teratoma
Trial Start Date		1997-07-01
Registered in ClinicalTrials.gov		NCT00003420
Date Submitted to PDQ		1998-07-09
Information Last Verified		2002-12-05