From: Protocol for the P3BEP trial (ANZUP 1302): an international randomised phase 3 trial of accelerated versus standard BEP chemotherapy for adult and paediatric male and female patients with intermediate and poor-risk metastatic germ cell tumours
1. Age ≥ 11 years and ≤ 45 years on the date of randomisation
2. Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma), or exceptionally raised tumour markers (AFP ≥ 1000 ng/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.
3. Primary arising in testis, ovary, retro-peritoneum, or mediastinum
4. Metastatic disease or non-testicular primary
5. Intermediate or poor prognosis as defined by IGCC classification (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries).
6. Adequate bone marrow function with ANC ≥1.0 × 109/L. Platelet count ≥100 × 106/L
7. Adequate liver function where bilirubin must be ≤1.5 x ULN, except participants with Gilbert’s syndrome or if the elevations are due to hepatic metastases.
8. Adequate renal function
9. ECOG performance status of 0–3
10. Study treatment both planned and able to start within 14 days of randomisation
11. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments.
12. Able to provide signed, written informed consent
1. Other primary malignancy
2. Previous chemotherapy or radiotherapy, except
a. Pure seminoma that relapsed after adjuvant radiotherapy or chemotherapy with 1–2 cycles of cisplatin
b. Non-seminoma and poor prognosis by IGCCC criteria in the rare case where low dose induction chemotherapy is given prior to registration because patients is not fit enough to receive protocol chemotherapy.
c. Participants who need to start therapy urgently prior to completing study-specific baseline investigations
3. Significant cardiac disease
4. Significant co-morbid respiratory disease
5. Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss
6. Concurrent illness that prevent the completion of the interventions listed in the protocol
7. Participants who are sexually active and are not willing to use an effective contraceptive method during this study.
8. Known allergy or hypersensitivity to any of the study drugs
9. Presence of any psychological, familial, sociological or geographical condition that the investigators believe will lead to compliance issues.