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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

Gordon J. Rustin, Graham M. Mead, Sally P. Stenning, Paul A. Vasey, Nina Aass, Robert A. Huddart, Michael P. Sokal, Jonathan K. Joffe, Stephen J. Harland, Sarah J. Kirk

From the Mount Vernon Cancer Centre, Middlesex; Royal South Hants Hospital, Southampton; Medical Research Council Clinical Trials Unit; The Middlesex Hospital, London; Beatson Oncology Centre, Glasgow; Royal Marsden Hospital, Sutton; Nottingham City Hospital, Nottingham; Cookridge Hospital, Leeds, United Kingdom; and Norwegian Radium Hospital, Oslo, Norway

Address reprint requests to Gordon J. Rustin, MD, Mount Vernon Cancer Centre, Northwood, Middlesex HA62RN, United Kingdom; e-mail: grustin{at}nhs.net

Purpose 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.

Conclusion 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.

Presented at the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2006, Atlanta, GA.

For a list of trial participants, please see the online-only Appendix.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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