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:
Publications and presentations
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.