Clinical trial NCT03142802: Low-Dose CT - Stage I Testicular Cancer
Official title: Phase II Study of Effectiveness of Using Low-dose CT in Patient Undergoing Surveillance for Clinical Stage I Testicular Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Testicular Cancer
Keywords: Testicular cancer
low-dose CT
CT scan
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 251
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients diagnosed with testicular germ cell cancer will undergo both standard and low dose CT scan of the abdomen and pelvis.
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* Phase A:
* 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
* Phase B:
* 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

Primary outcomes:
measure: Difference in size of the retroperitoneal lymph node mass
timeFrame: 9 years
Secondary outcomes:
measure: Time on surveillance
timeFrame: 6 years
measure: Amount of false positive rate of LDCTs
timeFrame: 6 years
measure: Proportion of patients unsuitable for LDCT surveillance
timeFrame: 6 years
measure: Proportion of patients who have to discontinue LDCT surveillance
timeFrame: 6 years
measure: Amount of prospective identification of first modality to detect relapse
timeFrame: 6 years
measure: Proportion of disease-free survival
timeFrame: 6 years
measure: Proportion of overall survival
timeFrame: 6 years
measure: Amount of prospective documentation of treatment for testicular germ cell cancer relapse
timeFrame: 6 Years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: The Princess Margaret Cancer Foundation
name: Peter Chung
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chung P, O'Malley ME, Jewett MAS, Bedard PL, Panzarella T, Sturgeon J, Moore MJ, Hamilton R, Hansen AR, Anson-Cartwright L, Gospodarowicz M, Warde P. Detection of Relapse by Low-dose Computed Tomography During Surveillance in Stage I Testicular Germ Cell Tumours. Eur Urol Oncol. 2019 Jul;2(4):437-442. doi: 10.1016/j.euo.2018.08.031. Epub 2018 Oct 2.