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111 trial

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 cancerurological cancers 

Treatment modality: Systemic therapy

Status: In follow up

Trial details

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.

Further information

Chief Investigator: Professor Michael Cullen, Queen Elizabeth Hospital, Birmingham

ICR-CTSU Scientific Lead: Dr Emma Hall

Trial management contact: [email protected]

ISRCTN: 37875250

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:

UKCRN portfolio 

Patient friendly information is available from the following link:

CancerHelp UK 

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.

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.