Follow-up Evaluation Using CT Scans in Patients Who Have Been Treated For Metastatic Testicular Cancer

Royal Marsden NHS Foundation Trust

Status: Unknown

Conditions: Testicular Germ Cell Tumor

Treatments: Procedure: computed tomography; Other: biomarker analysis

Study type: Observational

Funder types: Other

Identifiers

NCT00553371

ICR-RMH-NSGCT

EU-20770

CDR0000573199

Details and patient eligibility

About

RATIONALE: Learning about long-term effects in patients with testicular cancer may help doctors plan better treatment and follow-up care.

PURPOSE: This clinical trial is using CT scans to follow patients who have been treated for metastatic testicular cancer.

Full description

OBJECTIVES:

• To assess the frequency of relapse or recurrent abnormalities detected by CT scan in patients on long-term follow-up for metastatic nonseminomatous germ cell tumour (NSGCT).
• To assess the utility of CT scan-assessment in these patients.
• To assess the prognostic factors predictive of late relapse in NSGCT.

OUTLINE: This is a multicenter study.

Patients are screened by CT scan of the chest, abdomen, and pelvis for detectable abnormalities or indications of late relapse. Scans are classified as positive or negative, according to standard CT criteria, by a radiologist with expertise in testicular cancer imaging. Patients with negative scans are followed yearly by clinical examination and tumor marker assessment, and every 5 years by CT imaging. Additional follow-up is performed at the discretion of the attending physician. Patients with positive scans undergo confirmation of relapse, whenever possible, by surgical excision or biopsy and treatment is initiated according to best clinical practice. If the follow-up scan is equivocal, patients are advised to have a follow-up scan of the affected region in 6 months.

Enrollment: 300 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic nonseminomatous germ cell tumor (NSGCT) at risk of developing late relapse of residual abnormality

  • Royal Marsden Hospital stage II-IV disease

• Treatment for NSGCT completed within the past 5 to10 years

  • No evidence of disease after completion of chemotherapy, as demonstrated by negative CT scans within the past 3 years

PATIENT CHARACTERISTICS:

• Willing to attend follow-up for five years
• No contraindication to CT imaging

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics