A single group trial evaluating one cycle of adjuvant bleomycin, etoposide and cisplatin chemotherapy in high risk, stage 1 non seminomatous germ cell tumours of the testis.
Disease site: Testicular cancer, urological cancers
Treatment modality: Systemic therapy
Status: In follow up
The 111 trial is a phase III, single group, multicentre study to evaluate whether one cycle of adjuvant bleomycin, etoposide and cisplatin (BEP) chemotherapy results in a 2 year recurrence rate of less than 5% in patients with high risk, stage 1 non seminomatous germ cell tumours of the testis (NSGCTT).
246 patients with histologically proven NSGCTT or mixed germ cell tumours with vascular invasion and stage 1 disease within 6 weeks of having orchidectomy were recruited from 33 UK sites over 4.5 years. Patients received a single cycle of adjuvant BEP chemotherapy and are being followed up annually following completion of treatment.
Chief Investigator: Professor Michael Cullen, Queen Elizabeth Hospital, Birmingham
ICR-CTSU Scientific Lead: Dr Emma Hall
Trial management contact: [email protected]
Sponsors: The Institute of Cancer Research and University Hospitals Birmingham NHS Foundation Trust
Funding: Cancer Research UK (CRUK/09/011) and Queen Elizabeth Hospital Birmingham Charity
Further information including recruitment progress is available from the following link:
Patient friendly information is available from the following link:
Further information is available at UK Clinical Trials Gateway
Publications and presentations
111 Lay Summary of Results
Cullen, M, Huddart, R, Joffe, J, Gardiner, D, Maynard, L, Hutton, P, Mazhar, D, Shamash, J, Wheater, M, White, J, Goubar, A, Porta, N, Witts, S, Lewis, R, Hall, E. The 111 Study: A Single-arm, Phase 3 Trial Evaluating One Cycle of Bleomycin, Etoposide, and Cisplatin as Adjuvant Chemotherapy in High-risk, Stage 1 Nonseminomatous or Combined Germ Cell Tumours of the Testis. Eur Urol, 77 (2020), pp. 344-351
Hall E, Cruickshank C, Joffe J, Huddart R, Cullen M; on behalf of the 111 Trial Management Group. Trial design in rare cancers: 111 – a single group non-randomised trial in non-seminomatous germ cell tumours of the testis (NSGCTT) (CRUK/09/011). Poster session presented at: 7th National Cancer Research Institute Cancer Conference; 2011 Nov 6-9; Liverpool, UK.
Kalaitzaki E, A’Hern R, Cullen M, Stenning S, Hall E. Monitoring rare events in a single arm non-inferiority trial (111; CRUK/09/011). Presented at: Society for Clinical Trials 33rd Annual Meeting; 2012 May 20-23; Miami, FL, USA.