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 |
| EudraCT/CTIS number | 2008-006295-29 |
| IRAS number | 1866 |
| ClinicalTrials.gov number | NCT01726374 |
| Secondary identifying numbers | ICR-CTSU/2008/10019, IRAS 1866 |
- Submission date
- 25/03/2009
- Registration date
- 14/05/2009
- Last edited
- 01/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
http://www.cancerhelp.org.uk/trials/a-trial-single-cycle-chemotherapy-testicular-cancer-111-trial
Contact information
Prof Michael Cullen
Scientific
Scientific
Department of Oncology
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
Study information
| Study design | Non-randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 hypothesis | 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 |
| Condition | 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 Joint sponsor: University Hospitals Birmingham NHS Trust (UK) Research and Development Queen Elizabeth Hospital Queen Elizabeth Medical Centre Birmingham, B15 2TH United Kingdom |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Bleomycin, etoposide, cisplatin (BEP) chemotherapy |
| Primary outcome measure | Recurrence at 2 years (trial aims to show a 2 year recurrence rate of less that 5%). |
| Secondary outcome measures | 1. Immediate and delayed toxicity (CTC) including long-term permanent infertility (greater than 2 years) 2. Contralateral second primary testicular germ cell malignancy 3. Relapse free survival 4. Overall survival Measurement timings are between 4 - 5 years approximately with a yearly review of trial data by the Independent Data Monitoring Committee (IDMC). |
| Overall study start date | 01/06/2009 |
| Overall study end date | 31/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 236 |
| Total final enrolment | 246 |
| Participant 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. |
| Participant 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 |
| Recruitment start date | 01/06/2009 |
| Recruitment end date | 31/07/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Oncology
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
Institute of Cancer Research (UK)
Research organisation
Research organisation
123 Old Brompton Road
London
SW7 3RP
United Kingdom
| Website | http://www.icr.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/043jzw605 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 01/03/2020 | 24/02/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
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.
