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

United Kingdom Research and Innovation (UKRI)

Status: Completed

Conditions: Testicular Germ Cell Tumor

Treatments: Procedure: computed tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT00003420

ISRCTN56475197

EU-98007

CDR0000066440

MRC-TE08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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