Accelerated Bleomycin, Etoposide, Platinum (BEP) chemotherapy for intermediate and high risk metastatic germ cell tumour

ISRCTN	ISRCTN18505589
DOI	https://doi.org/10.1186/ISRCTN18505589
ClinicalTrials.gov (NCT)	NCT00453232
Clinical Trials Information System (CTIS)	2004-000847-79
Protocol serial number	A090011
Sponsor	Cambridge University NHS Foundation Trust (UK)
Funders	Investigator initiated and funded (UK), Amgen (UK) - providing discounted Neulasta® (pegfilgrastim) 6 mg/0.6 ml syringes

Submission date: 21/04/2008
Registration date: 16/05/2008
Last edited: 26/10/2018

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 of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-two-weekly-bep-chemotherapy-for-germ-cell-tumours-in-men

Contact information

Dr Michael Williams
Scientific

Oncology Centre (Box 193)
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Study information

Primary study design	Interventional
Study design	Multicentre non-randomised single-arm registration/interventional trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A non-randomised phase II pilot study of Accelerated Bleomycin, Etoposide, Platinum (BEP) chemotherapy for intermediate and high risk metastatic germ cell tumours
Study acronym	Accelerated BEP
Study objectives	To assess the tolerability and toxicity of an accelerated regimen of chemotherapy in patients with germ cell tumours.
Ethics approval(s)	Eastern Multicentre Research Ethics Committee, 07/04/2004, ref: 04/5/024
Health condition(s) or problem(s) studied	Metastatic germ cell tumour
Intervention	Day 1: etoposide (165 mg/m^2)/cisplatin (50 mg/m^2) (intravenous [IV] infusions) Day 2: etoposide (165 mg/m^2)/cisplatin (50 mg/m^2)/bleomycin (30,000 units) (IV infusions) Day 3: etoposide (165 mg/m^2) Day 4: granulocyte colony-stimulating factor (G-CSF) injection (6 mg) Day 6, 7 or 8: bleomycin (30,000 units) (IV infusion) Day 10, 11 or 12: bleomycin (30,000 units) (IV infusion) This is a single armed trial. Patients are followed-up according to institutional practice, however, the study requires computed tomography (CT), audiometry and lung function tests to be performed at one and two years post-chemotherapy.
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Bleomycin, etoposide, platinum (BEP) chemotherapy
Primary outcome measure(s)	The primary endpoint of feasibility will be judged by the results of all of the data via a risk-benefit analysis. Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0 criteria during treatment, and then via CR51-EDTA for renal function (pre-treatment versus post-treatment). Audiometry and lung function tests (pulmonary vital capacity and diffusing capacity of the lung for carbon monoxide [DLCO]) are standard assessments performed. There is also a clinical assessment of neurotoxicity (including two-point discrimination, Romberg test, tendon reflexes and vibration test, along with NCI CTC neuropathy-motor toxicity and neuro-sensory toxicity assessments). The patients are also given a simple questionnaire regarding tingling, burning and weakness they have experienced; its location, frequency and impact.
Key secondary outcome measure(s)	1. To establish the response rate to this treatment 2. To establish progression free survival
Completion date	01/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	20
Key inclusion criteria	Patients must fulfill all of the following criteria in a particular category: 1. Non-seminoma germ cell tumour (intermediate risk): 1.1. Testis or retroperitoneal primary 1.2. Abnormal markers as below: 1.2.1. Alpha-fetoprotein (AFP) greater than 1,000 and less than 10,000 ng/ml 1.2.2. Human chorionic gonadotropin (HCG) greater than 5,000 and less than 50,000 iu/l 1.2.3. Lactate dehydrogenase (LDH) greater than 1.5 x to less than 10 x the upper limit of normal 1.3. No liver, bone, brain or other non-pulmonary visceral metastasis 1.4. Histological confirmation of non-seminomatous germ cell tumours (NSGCT) is not required if AFP or HCG are grossly elevated 2. Non-seminoma germ cell tumour (poor prognosis): 2.1. Mediastinal primary, or 2.2. Non-pulmonary visceral metastases, or 2.3. Poor markers - any of AFP greater than 10,000 ng/ml, HCG greater than 50,000 iu/l, LDH greater than 10 x upper limit of normal 2.4. Histological confirmation of NSGCT is not required if AFP or HCG are grossly elevated 3. Seminoma (intermediate prognosis): 3.1. Histological confirmation of seminoma is required 3.2. Any primary site 3.3. Non-pulmonary visceral metastases must be present 3.4. Normal AFP 3.5. Any HCG 3.6. Any LDH
Key exclusion criteria	1. Aged less than 18 years or over 40 years 2. Female patients 3. Previous malignancy except basal cell carcinoma of the skin 4. Previous chemotherapy or radiotherapy 5. Inadequate renal function - patients with creatinine clearance below 60 ml/min are excluded unless this is due to obstructive uropathy which can be relieved by nephrostomy 6. Neutrophils less than 1.0 x 10^9/L, platelets less than 100,000 prior to commencing treatment 7. Patient unable to understand and consent in English unless a full interpreter service is provided including translation of all documents or the provision of a tape recording of the consultation
Date of first enrolment	01/08/2004
Date of final enrolment	01/08/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Addenbrooke's Hospital

Cambridge
CB2 0QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	06/09/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes

Editorial Notes

26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
13/10/2017: Publication reference added.