Condition category
Cancer
Date applied
25/03/2009
Date assigned
14/05/2009
Last edited
30/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Michael Cullen

ORCID ID

Contact details

Department of Oncology
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01726374

Protocol/serial number

ICR-CTSU/2008/10019

Study information

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)

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

South East REC, 20/08/2009, ref: 09/H1102/86

Study design

Non-randomised controlled trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Phase III

Drug names

Bleomycin, etoposide, cisplatin (BEP) chemotherapy

Primary outcome measures

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 trial start date

01/06/2009

Overall trial end date

18/03/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Male

Target number of participants

236

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

18/03/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Oncology
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

Institute of Cancer Research (UK)

Sponsor details

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Sponsor type

Research organisation

Website

http://www.icr.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/09/2016: No publications found, verifying study status with principal investigator