Randomized trial of two or five computed tomography scans in the surveillance of patients with stage I nonseminomatous germ cell tumors of the testis: Medical Research Council Trial TE08, ISRCTN56475197--the National Cancer Research Institute Testis Cancer Clinical Studies Group.
OBJECTIVE
Surveillance is a standard management approach for stage I nonseminomatous germ cell tumors (NSGCT). A randomized trial of two versus five computed tomography (CT) scans was performed to determine whether the number of scans influenced the proportion of patients relapsing with intermediate- or poor-prognosis disease at relapse.


METHODS
Patients with clinical stage I NSGCT opting for surveillance were randomly assigned to chest and abdominal CT scans at either 3 and 12 or 3, 6, 9, 12, and 24 months, with all other investigations identical in the two arms. Three of five patients were allocated to the two-scan schedule. Four hundred patients were required.


RESULTS
Two hundred forty-seven patients were allocated to a two-scan and 167 to five-scan policy. With a median follow-up of 40 months, 37 relapses (15%) have occurred in the two-scan arm and 33 (20%) in the five-scan arm. No patients had poor prognosis at relapse, but two (0.8%) of those relapsing in the two-scan arm had intermediate prognosis compared with 1 (0.6%) in the five-scan arm, a difference of 0.2% (90% CI, -1.2% to 1.6%). No deaths have been reported.


CONCLUSIONS
This study can rule out with 95% probability an increase in the proportion of patients relapsing with intermediate- or poor-prognosis disease of more than 1.6% if they have two rather than five CT scans as part of their surveillance protocol. CT scans at 3 and 12 months after orchidectomy should be considered a reasonable option in low-risk patients.
Rustin
Gordon J
GJ
Mount Vernon Cancer Centre, Northwood, Middlesex HA62RN, United Kingdom. grustin@nhs.net
Mead
Graham M
GM
Stenning
Sally P
SP
Vasey
Paul A
PA
Aass
Nina
N
Huddart
Robert A
RA
Sokal
Michael P
MP
Joffe
Jonathan K
JK
Harland
Stephen J
SJ
Kirk
Sarah J
SJ
D000328:Adult; D001315:Australia / Q000453:epidemiology; D016009:Chi-Square Distribution; D018450:Disease Progression; D006801:Humans; D008297:Male; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D009373:Neoplasms, Germ Cell and Embryonal / Q000000981:diagnostic imaging* / Q000453:epidemiology / Q000473:pathology; D009520:New Zealand / Q000453:epidemiology; D009664:Norway / Q000453:epidemiology; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D013736:Testicular Neoplasms / Q000000981:diagnostic imaging* / Q000453:epidemiology / Q000473:pathology; D014057:Tomography, X-Ray Computed / Q000706:statistics & numerical data*; D006113:United Kingdom / Q000453:epidemiology