Accelerated Bleomycin, Etoposide, Platinum (BEP) chemotherapy for intermediate and high risk metastatic germ cell tumour
| ISRCTN | ISRCTN18505589 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18505589 |
| EudraCT/CTIS number | 2004-000847-79 |
| ClinicalTrials.gov number | NCT00453232 |
| Secondary identifying numbers | A090011 |
- 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
Contact information
Dr Michael Williams
Scientific
Scientific
Oncology Centre (Box 193)
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Study information
| Study design | Multicentre non-randomised single-arm registration/interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Bleomycin, etoposide, platinum (BEP) chemotherapy |
| Primary outcome measure | 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. |
| Secondary outcome measures | 1. To establish the response rate to this treatment 2. To establish progression free survival |
| Overall study start date | 01/08/2004 |
| Completion date | 01/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Sponsor information
Cambridge University NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Box 277
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Website | http://www.addenbrookes.org.uk/ |
|---|---|
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Other
Investigator initiated and funded (UK)
No information available
Amgen (UK) - providing discounted Neulasta® (pegfilgrastim) 6 mg/0.6 ml syringes
No information available
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 | 06/09/2011 | Yes | No |
Editorial Notes
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
13/10/2017: Publication reference added.
