111 trial

• Research type

  Research Study

• Full title

  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).

• IRAS ID

  1866

• Contact name

  Mike Cullen

• Sponsor organisation

  The Institute of Cancer Research

• Eudract number

  2008-006295-29

• ISRCTN Number

  37875250

• Research summary

  The 111 study is a single group multi-centre study evaluating a single cycle of BEP (bleomycin, etoposide and cisplatin) as adjuvant chemotherapy in high risk, stage 1 non-seminomatous germ cell tumours of the testis (NSGCTT). Data from a previous single group UK trial (reference no. 1) of two cycles of BEP chemotherapy suggest two year recurrence-free survival of 98% in high-risk stage 1 NSGCTT. This study was able to exclude a true recurrence rate of more than 5%. BEPx2 is now standard practice in many parts of the world. Some data suggest that a single chemotherapy cycle might be as effective but the evidence is not strong enough to change practice. The proposed study would add significantly to this data. The aim 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 (vascular invasion positive) stage 1 NSGCTT. Halving the number of chemotherapy cycles given is also expected to reduce short- and long-term toxicity allowing young men to return to normal life more quickly. It would also reduce the overall burden of chemotherapy and healthcare resource usage. The minimum sample size is 236 patients. Events will be closely monitored and the trial terminated should the predicted recurrence risk equal or exceed 5%. Reference 1: Cullen MH, Stenning SP, Parkinson MC, et al. Short course adjuvant chemotherapy in high-risk stage 1 non-seminomatous germ cell tumours of the testis: a Medical Research Council report. J Clin Oncol 1996, vol. 14; 4: 1106-1113

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/86

• Date of REC Opinion

  20 Aug 2009

• REC opinion

  Favourable Opinion