About this trial
The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.
Eligibility criteria
Qualifiers
Age ≥ 11 years and ≤ 50 years on the date of randomisation
Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or Exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently
Primary arising in testis, ovary, retro-peritoneum, or mediastinum
Metastatic disease or non-testicular primary
Disqualifiers
Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)
Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin or if patient hasb. non-seminoma by IGCCC criteria or stage IV malignant ovarian germ cell tumour in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (eg. organ failure, vena cava obstruction, overwhelming burden of disease). Acceptable regimens include cisplatin 20 mg/m2 days 1-2 and etoposide 100 mg/m2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m2 days 1-2; or baby-BOP.43 Patients must meet all other inclusion and exclusion criteria at the time of registration.
Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
Significant co-morbid respiratory disease that contraindicates the use of bleomycin
Trial design
Treatments tested in this trial
- Bleomycin (active name: Bleomycin Sulfate)
- Etoposide
- Cisplatin
- Pegylated G-CSF (Pegfilgrastim)
- Filgrastim
Treatment groups
Sponsors and collaborators
University of Sydney
Lead sponsor
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Collaborator
Cambridge University Hospitals NHS Foundation Trust
Collaborator
Cancer Trials Ireland
Collaborator
Children's Oncology Group
Collaborator
Dana-Farber Cancer Institute
Collaborator
University of Southern California
Collaborator