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


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Trial ID: NCT02582697


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.

Official Title

Phase 3 Accelerated BEP: A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours

Stanford Investigator(s)


Inclusion Criteria:

   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 ≥ 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

   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 IGCCC classification3 (modified with
   different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian
   primaries). (See protocol for more information).

   6. Adequate bone marrow function with ANC ≥1.0 x 10^9/L, Platelet count ≥100 x 10^9/L

   7. Adequate liver function where bilirubin must be ≤1.5 x ULN, except participants with
   Gilbert's Syndrome where bilirubin must be ≤2.0 x ULN; ALT and AST must be ≤2.5 x ULN,
   except if the elevations are due to hepatic metastases, in which case ALT and AST must
   be ≤ 5 x ULN

   8. Adequate renal function with estimated creatinine clearance of ≥60 ml/min according to
   the Cockcroft-Gault formula, unless calculated to be < 60 ml/min or borderline in
   which case GFR should be formally measured, eg. with EDTA scan

   9. ECOG Performance Status of 0, 1, 2, or 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

Exclusion Criteria:

   1. 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)

   2. 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 has non-seminoma and poor prognosis by IGCCC criteria 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). In these instances acceptable
   regimens include cisplatin 20 mg/m^2 days 1-2 and etoposide 100 mg/m^2 days 1-2;
   carboplatin AUC 3 days 1-2 and etoposide 100 mg/m^2 days 1-2; or baby-BOP. Patients
   must meet all other inclusion and exclusion criteria at the time of registration.

   Additionally participants who need to start therapy urgently prior to completing
   study-specific baseline investigations may commence study chemotherapy prior to
   registration and randomisation. Such patients must be discussed with the coordinating
   centre prior to registration, and must be registered within 10 days of commencing
   study chemotherapy.

   3. Significant cardiac disease resulting in inability to tolerate IV fluid hydration for

   4. Significant co-morbid respiratory disease that contraindicates the use of bleomycin

   5. Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss
   or tinnitus

   6. Concurrent illness, including severe infection that may jeopardize the ability of the
   participant to undergo the procedures outlined in this protocol with reasonable safety

   7. Inadequate contraception. Men must use 2 effective methods of contraception, including
   use of a condom, during chemotherapy and for a year after completing chemotherapy.

   8. Known allergy or hypersensitivity to any of the study drugs

   9. Presence of any psychological, familial, sociological or geographical condition that
   in the opinion of the investigator would hamper compliance with the study protocol and
   follow-up schedule, including alcohol dependence or drug abuse

The above inclusion and exclusion criteria will apply to stage 1 (n=150) and stage 2 (n=500
including stage 1) of the study. All sites will participate in both stages of the study
with the exception of the Children's Oncology Group who will be participate in stage 1


drug: Bleomycin (active name: Bleomycin Sulfate)

drug: Etoposide

drug: Cisplatin

drug: Pegylated G-CSF (Pegfilgrastim)

drug: Filgrastim


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ariel Fry Demetria

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