Clinical trial NCT00553371: Follow-up Evaluation Using CT Scans in Patients Who Have Been Treated For Metastatic Testicular Cancer
Official title: Assessment of the Utility of CT Follow Up in the Long Term Follow Up of Patients With Metastatic Non Seminomatous Germ Cell Tumour (NSGCT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Testicular Germ Cell Tumor
Keywords: stage II malignant testicular germ cell tumor
stage III malignant testicular germ cell tumor
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-11-04
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Rate of abnormalities due to nonseminomatous germ cell tumour (NSGCT) detected on initial CT-scan
Secondary outcomes:
measure: Rate of false positive abnormalities not due to NSGCT but due to benign process
measure: Rate of relapse following initial CT scan
measure: Number of abnormalities detected on second CT scan
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden - Surrey
state: England
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Robert A. Huddart, MD
role: STUDY_CHAIR
References: