This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Rustin, G. J. Articles by Kirk, S. J. Search for Related Content PubMed PubMed Citation Articles by Rustin, G. J. Articles by Kirk, S. J. Social Bookmarking                            What's this?

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.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				H.-J. Schmoll, K. Jordan, R. Huddart, M. P. Laguna, A. Horwich, K. Fizazi, V. Kataja, and On behalf of the ESMO Guidelines Working Group Testicular non-seminoma: ESMO Clinical Recommendations for diagnosis, treatment and follow-up Ann. Onc., May 1, 2009; 20(suppl_4): iv89 - iv96. [Full Text] [PDF]

				C. J. Pezaro, G. Mallesara, and G. C. Toner Late Relapsing Stage I Nonseminoma J. Clin. Oncol., December 1, 2008; 26(34): 5647 - 5648. [Full Text] [PDF]

				S. A. Sohaib, D.-M. Koh, and J. E. Husband The Role of Imaging in the Diagnosis, Staging, and Management of Testicular Cancer Am. J. Roentgenol., August 1, 2008; 191(2): 387 - 395. [Abstract] [Full Text] [PDF]

				R. A. Huddart, M. J. O'Doherty, A. Padhani, G. J.S. Rustin, G. M. Mead, J. K. Joffe, P. Vasey, S. J. Harland, J. Logue, G. Daugaard, et al. 18Fluorodeoxyglucose Positron Emission Tomography in the Prediction of Relapse in Patients With High-Risk, Clinical Stage I Nonseminomatous Germ Cell Tumors: Preliminary Report of MRC Trial TE22 The NCRI Testis Tumour Clinical Study Group J. Clin. Oncol., July 20, 2007; 25(21): 3090 - 3095. [Abstract] [Full Text] [PDF]

				CT Scans in Surveillance of Stage I Nonseminomatous Testicular Cancers Journal Watch Oncology and Hematology, May 2, 2007; 2007(502): 2 - 2. [Full Text]

				R. de Wit Cutting Back on Computed Tomography Scan Frequency in Curative Oncology: Get the Picture J. Clin. Oncol., April 10, 2007; 25(11): 1308 - 1309. [Full Text] [PDF]