Phase II Study of Effectiveness of Using Low-dose CT in Patient Undergoing Surveillance for Clinical Stage I Testicular Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 251
- Locations
- 1
- Primary Endpoint
- Difference in size of the retroperitoneal lymph node mass
Study Overview
Brief Summary
Patients with primary germ cell cancer of the testicles confined to the testis can avoid adjuvant treatment by entering a surveillance protocol. In the surveillance protocol, patients are followed for up to ten years with serial computed tomography scans to detect recurrence. Multiple CT scans expose patients to a significant amount of radiation, which may be associated with an increased risk of secondary malignancies. This study hypothesizes that low dose CT scans are as effective as standard dose CT scans in detecting disease recurrence in this setting and will significantly reduce radiation exposure in this group of patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Newly diagnosed testicular germ cell testicular cancer (GCT) with no clinical or tumour marker evidence of metastases
- •Stage I disease according to UICC stage groupings and currently on surveillance (in Year 1 of non-seminoma surveillance or year 1 or 2 of seminoma surveillance)
- •ECOG performance status 0 or 1
- •Stage I disease according to UICC stage Groupings
- •Initial Low dose CT considered by study radiologist to be of sufficient quality to allow surveillance using LDCT protocol
Exclusion Criteria
- •any medical conditions that render the patient ineligible to undergo the protocol or procedure
Arms & Interventions
Patients with testicular germ cell cancer
Patients with testicular germ cell cancer who have either been newly diagnosed, or have stage I cancer already on surveillance program will undergo conventional and low dose CT. Based on the imaging, they may undergo a surveillance program using low-dose CT.
Intervention: Low-dose computed tomography (LDCT) (Diagnostic Test)
Outcomes
Primary Outcomes
Difference in size of the retroperitoneal lymph node mass
Time Frame: 9 years
The difference in size of lymph node mass at the time of relapse between low dose CT and conventional CT. This is to evaluate the effectiveness of using low-dose CT in patients undergoing surveillance.
Secondary Outcomes
- Amount of false positive rate of LDCTs(6 years)
- Amount of prospective identification of first modality to detect relapse(6 years)
- Amount of prospective documentation of treatment for testicular germ cell cancer relapse(6 Years)
- Proportion of disease-free survival(6 years)
- Time on surveillance(6 years)
- Proportion of patients who have to discontinue LDCT surveillance(6 years)
- Proportion of patients unsuitable for LDCT surveillance(6 years)
- Proportion of overall survival(6 years)