111 Trial

Disease site: Urological

Treatment Modality: Chemotherapy

Status: Open to recruitment

The 111 trial is a single group trial evaluating one cycle of adjuvant BEP chemotherapy in high risk, stage 1 non-seminomatous germ cell tumours of the testis (NSGCTT).

The trial’s primary objective is to show that one cycle of adjuvant BEP chemotherapy results in a two year recurrence rate of less than 5% in patients with high-risk, stage 1 NSGCTT. Secondary objectives are to evaluate the safety and tolerability of BEP chemotherapy including long term infertility.

236 newly diagnosed testicular cancer patients with histologically proven NSGCTT or mixed GCT with vascular invasion and stage 1 disease who are within 6 weeks of having orchidectomy will be recruited to the study, all of whom will receive a single cycle of adjuvant BEP chemotherapy.

The 111 trial opened to recruitment in February 2010.  Presentations from the launch meeting are available to participating centres below.  Each presentation is password protected, for password enquiries, please contact the Trial Manager at: 111-icrctsu@icr.ac.uk