One cycle of adjuvant bleomycin, etoposide, cisplatin (BEP) chemotherapy in high risk, stage one non-seminomatous germ cell tumours of the testis (NSGCTT)
| ISRCTN | ISRCTN37875250 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37875250 |
| ClinicalTrials.gov (NCT) | NCT01726374 |
| Clinical Trials Information System (CTIS) | 2008-006295-29 |
| Integrated Research Application System (IRAS) | 1866 |
| Protocol serial number | ICR-CTSU/2008/10019 |
| Sponsors | Institute of Cancer Research (UK), University Hospitals Birmingham NHS Foundation Trust |
| Funder | Cancer Research UK (CRUK) (UK) |
- Submission date
- 25/03/2009
- Registration date
- 14/05/2009
- Last edited
- 27/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
http://www.cancerhelp.org.uk/trials/a-trial-single-cycle-chemotherapy-testicular-cancer-111-trial
Contact information
Scientific
Department of Oncology
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomized controlled trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | A single group trial evaluating one cycle of adjuvant bleomycin, etoposide, cisplatin (BEP) chemotherapy in high risk, stage one non-seminomatous germ cell tumours of the testis (NSGCTT) |
| Study acronym | 111 |
| Study objectives | 111 is a single group trial of a single cycle of adjuvant bleomycin, etoposide, cisplatin (BEP500) chemotherapy in high risk stage one non-seminomatous germ cell tumours of the testis (NSGCTT). It aims to show a two year recurrence rate of less than 5%. As of 22/02/2011 the anticipated end date for this trial has been updated from 01/06/2012 to 18/03/2013. |
| Ethics approval(s) | South East REC, 20/08/2009, ref: 09/H1102/86 |
| Health condition(s) or problem(s) studied | Newly diagnosed non-seminomatous germ cell tumours of the testis (NSGCTT)/mixed germ cell tumours (MGCT) with vascular invasion and stage one disease |
| Intervention | Single cycle of adjuvant BEP chemotherapy comprising: 1. Cisplatin 50 mg/m^2 intravenous (IV) day 1 and day 2 2. Bleomycin 30,000 IU IV infusion day 1 or 2 and 30,000 IU IV/intramuscularly (IM) day 8 and day 15 3. Etoposide 165 mg/m^2 IV days 1, 2 and 3 Added 27/11/2025: Additional Data Linkage Information: Participants from this trial will also be included in the INTERACT project which will link to their data held by NHS England. For more information, please see the INTERACT website: https://www.icr.ac.uk/interact. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Bleomycin, etoposide, cisplatin (BEP) chemotherapy |
| Primary outcome measure(s) |
Recurrence at 2 years (trial aims to show a 2 year recurrence rate of less that 5%). |
| Key secondary outcome measure(s) |
1. Immediate and delayed toxicity (CTC) including long-term permanent infertility (greater than 2 years) |
| Completion date | 31/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 100 Years |
| Sex | Male |
| Target sample size at registration | 236 |
| Total final enrolment | 246 |
| Key inclusion criteria | 1. Histologically proven non-seminomatous germ cell tumour (GCT) or mixed GCT (MGCT) of the testis 2. Histological proven vascular invasion of the primary tumour into the testicular veins or lymphatics 3. Clinical stage I patients (normal alpha-fetoprotein [AFP] and human chorionic gonadotropin [HCG], or optimum marker decline approaching normal levels after orchidectomy, no evidence of metastases on computed tomography [CT] of the chest, abdomen and pelvis) 4. Men aged greater than or equal to 16 years 5. Creatinine clearance greater than 50 ml/min 6. No previous chemotherapy 7. White blood cells (WBC) greater than 1.5 x 10^9/l and platelets greater than 100 x 10^9/l 8. Fit to receive chemotherapy 9. Able to start BEP chemotherapy as part of 111 study within 6 weeks* of orchidectomy 10. Written informed consent *It is strongly recommended based on previous studies that adjuvant chemotherapy should start within 6 weeks of orchidectomy. However, if there are unavoidable delays this timescale can be extended to 8 weeks. |
| Key exclusion criteria | 1. All patients with seminoma 2. All patients with non-seminoma greater than clinical stage 1 3. All patients with no vascular invasion 4. Previous chemotherapy 5. Patients with second malignancy except contralateral testicular intraepithelial neoplasia (TIN) and contralateral germ cell tumour treated by orchidectomy and subsequent surveillance of more then 3 years 6. Co-morbidity precluding the safe administration of BEP chemotherapy 7. Patients with renal function impairment (creatinine clearance less than or equal to 50 ml/min) 8. Patients with liver function impairment (bilirubin greater than 1.25 x upper limit of normal [ULN] and/or aspartate aminotransferase [AST] greater than 2 x ULN) 9. Patients with pre-existing neuropathy 10. Patients with pulmonary fibrosis 11. Patients with serious illness or medical conditions incompatible with the protocol |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 31/07/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Birmingham
B15 2TH
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2020 | 24/02/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes | |||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/11/2025: The interventions were updated.
01/05/2020: Cancer Research UK lay results summary link added to Results (plain English).
20/03/2020: EudraCT number added.
24/02/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
3. The IRAS number has been added.
24/01/2019: The following changes have been made to the trial record:
1. The recruitment end date has been changed from 18/03/2013 to 31/07/2014
2. The overall trial end date has been changed from 18/03/2013 to 31/08/2019
30/09/2016: No publications found, verifying study status with principal investigator.
