Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age11-50
SponsorUniversity of Sydney

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

500 Participants
are divided into 2 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