111: Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis Tumours

Sponsor

Institute of Cancer Research, United Kingdom (Other)

Overall Status

Unknown status

CT.gov ID

NCT01726374

Collaborator

University Hospital Birmingham NHS Foundation Trust (Other), Cancer Research UK (Other)

246

Enrollment

Locations

Arm

126

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

High-risk stage 1 NSGCTTs are curable with careful surveillance followed by 3 cycles of BEP (bleomycin, etoposide, cisplatin with 500mg/m2 of etoposide per cycle) chemotherapy for the 40-50% of cases experiencing recurrence. Alternatively, adjuvant chemotherapy with 2 cycles of BEP(at a lower dose than that used for advanced disease - etoposide 360mg/m2) for these patients achieves the same outcome and avoids intensive surveillance, but delivers 33% more chemotherapy cycles on a population basis.

If a single cycle of BEP at the dose used in advanced disease had a similar high rate of relapse-free survival (cure) to that seen with two lower dose cycles, this would reduce the overall burden of chemotherapy and healthcare resource usage and would be likely to lead to a change in practice globally.

Condition or Disease	Intervention/Treatment	Phase
Stage I Testicular Non-Seminomatous Germ Cell Tumor	Drug: BEP(500)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

246 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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)

Actual Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Aug 1, 2016

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: One cycle adjuvant BEP(500) Etoposide 165 mg/m2 IV infusion - days 1, 2, 3 Cisplatin 50 mg/m2 IV infusion - days 1, 2 Bleomycin 30,000 IU IV infusion - days 1 (or 2), 8, 15	Drug: BEP(500) One cycle of BEP(500): Etoposide 165 mg/m2 IV infusion - days 1, 2, 3 Cisplatin 50 mg/m2 IV infusion - days 1, 2 Bleomycin 30,000 IU IV infusion - days 1 (or 2), 8, 15

Arm

Intervention/Treatment

Experimental: One cycle adjuvant BEP(500)

Etoposide 165 mg/m2 IV infusion - days 1, 2, 3 Cisplatin 50 mg/m2 IV infusion - days 1, 2 Bleomycin 30,000 IU IV infusion - days 1 (or 2), 8, 15

Drug: BEP(500)

One cycle of BEP(500): Etoposide 165 mg/m2 IV infusion - days 1, 2, 3 Cisplatin 50 mg/m2 IV infusion - days 1, 2 Bleomycin 30,000 IU IV infusion - days 1 (or 2), 8, 15

Outcome Measures

Primary Outcome Measures

Recurrence [2 years]
To demonstrate that one cycle of adjuvant BEP(500) reduces 2 year recurrence rate to less than 5%

Secondary Outcome Measures

Immediate and delayed toxicity including long-term permanent infertility (>2 years) [0 - > 2 years]
Relapse free survival [Patients followed up for 5 years]
Overall survival [Patients followed up for 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically proven non-seminomatous germ cell tumour of combined GCT (NSGCT + seminoma)of the testis
Histologically proven vascular invasion of the primary tumour into the testicular veins or lymphatics
Clinical stage 1 patients (normal AFP and HCG, or optimum marker decline approaching normal levels after orchidectomy AND no evidence of metastases on CT of chest, abdomen and pelvis)
Men aged 16 years or over
Creatinine clearance > 50 ml/min
No previous chemotherapy
WBC > 1.5 x 10^{9/l and platelets 100 x 10}9/l
Fit to receive chemotherapy
Able to start BEP(500) chemotherapy as part of 111 study within 6* weeks of orchidectomy
Written informed consent *If there are unavoidable delays this timescale can be extended to 8 weeks

Exclusion Criteria:

All patients with pure seminoma
All patients with non-seminoma or combined NSGCT + seminoma > stage 1
All patients with no vascular invasion
Previous chemotherapy
Patients with second malignancy except contralateral TIN and contralateral germ cell tumour treated by orchidectomy and subsequent surveillance of more than 3 years
Co-morbidity precluding the safe administration of BEP(500) chemotherapy
Patients with renal function impairment (bilirubin >1.25 x ULN and/or AST >2 x ULN)
Patients with pre-existing neuropathy
Patients with pulmonary fibrosis
Patients with serious illness or medical conditions incompatible with the protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guy's Hospital	London	England	United Kingdom	SE1 9RT
2	Northampton General Hospital NHS Trust	Northampton	England	United Kingdom	NN6 8BJ
3	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales	United Kingdom	CF14 2TL
4	Aberdeen Royal Infirmary	Aberdeen		United Kingdom
5	Ysbyty Gwynedd	Bangor		United Kingdom
6	Queen Elizabeth Hospital	Birmingham		United Kingdom
7	Royal Sussex County Hospital	Brighton		United Kingdom
8	Bristol Haematology and Oncology Centre	Bristol		United Kingdom
9	Queen's Hospital	Burton-on-Trent		United Kingdom
10	Addenbrooke's Hospital	Cambridge		United Kingdom
11	Cheltenham General Hospital	Cheltenham		United Kingdom
12	Gloucestershire Royal Hospital	Cheltenham		United Kingdom
13	University Hospitals Coventry and Warwickshire NHS Trust	Coventry		United Kingdom
14	Royal Derby Hospital	Derby		United Kingdom
15	Western General Hospital	Edinburgh		United Kingdom
16	Royal Devon and Exeter Hospital	Exeter		United Kingdom
17	Beatson West of Scotland Cancer Centre	Glasgow		United Kingdom
18	Royal Surrey County Hospital	Guildford		United Kingdom
19	Castle Hill Hospital	Hull		United Kingdom
20	Ipswich Hospital	Ipswich		United Kingdom
21	St James's University Hospital	Leeds		United Kingdom
22	Leicester Royal Infirmary	Leicester		United Kingdom
23	Lincoln County Hospital	Lincoln		United Kingdom
24	Clatterbridge Centre for Oncology	Liverpool		United Kingdom
25	Royal Liverpool University Hospital	Liverpool		United Kingdom
26	St Bartholomew's Hospital	London		United Kingdom
27	University College Hospital	London		United Kingdom
28	Maidstone Hospital	Maidstone		United Kingdom
29	James Cook University Hospital	Middlesbrough		United Kingdom
30	Norfolk and Norwich University Hospital	Norwich		United Kingdom
31	Nottingham City Hospital	Nottingham		United Kingdom
32	Churchill Hospital	Oxford		United Kingdom
33	Weston Park Hospital	Sheffield		United Kingdom
34	Southampton General Hospital	Southampton		United Kingdom
35	Royal Marsden Hospital	Sutton		United Kingdom

Sponsors and Collaborators

Institute of Cancer Research, United Kingdom
University Hospital Birmingham NHS Foundation Trust
Cancer Research UK

Investigators

Principal Investigator: Professor Michael Cullen, University Hospital Birmingham NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institute of Cancer Research, United Kingdom

ClinicalTrials.gov Identifier:

NCT01726374

Other Study ID Numbers:

ICR-CTSU/2008/10019
ISRCTN37875250
2008-006295-29
09/H1102/86
CRUK/09/011

First Posted:

Nov 14, 2012

Last Update Posted:

May 4, 2020

Last Verified:

Apr 1, 2020

Additional relevant MeSH terms:

Neoplasms, Germ Cell and Embryonal

Testicular Neoplasms

Study Results

No Results Posted as of May 4, 2020