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

  • STATUS
    Recruiting
  • End date
    Jul 12, 2023
  • participants needed
    500
  • sponsor
    University of Sydney
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Updated on 12 November 2020
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platelet count
renal function
filgrastim
etoposide
human chorionic gonadotropin
metastasis
neutrophil count
g-csf
cancer chemotherapy
bleomycin
alpha fetoprotein
pegfilgrastim
testicular
seminoma
mg++

Summary

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.

Description

Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). Cure rates are over 90% for good-risk disease, 85% with intermediate-risk, and about 70% for poor-risk disease. Previous strategies to improve first-line chemotherapy have failed to improve cure rates and were more toxic than BEP. New strategies are needed for patients with intermediate and poor-risk disease. BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) is conducting a trial comparing accelerated BEP with standard BEP. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.

Details
Treatment cisplatin, filgrastim, etoposide, Bleomycin (active name: Bleomycin Sulfate), Pegylated G-CSF (Pegfilgrastim)
Clinical Study IdentifierNCT02582697
SponsorUniversity of Sydney
Last Modified on12 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 11 yrs and 45 yrs?
Gender: Male or Female
Do you have Germ cell tumor?
Do you have any of these conditions: Germ Cell Tumors or Germ cell tumor?
Age 11 years and 45 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
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)
Adequate bone marrow function with ANC 1.0 x 10^9/L, Platelet count 100 x 10^9/L
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
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
ECOG Performance Status of 0, 1, 2, or 3
Study treatment both planned and able to start within 14 days of randomisation
Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments
Able to provide signed, written informed consent

Exclusion Criteria

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 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
\. Significant cardiac disease resulting in inability to tolerate IV fluid
hydration for cisplatin
\. Significant co-morbid respiratory disease that contraindicates the use of
bleomycin
\. Peripheral neuropathy grade 2 or clinically significant sensorineural
hearing loss or tinnitus
\. Concurrent illness, including severe infection that may jeopardize the
ability of the participant to undergo the procedures outlined in this protocol
with reasonable safety
\. Inadequate contraception. Men must use 2 effective methods of
contraception, including use of a condom, during chemotherapy and for a year
after completing chemotherapy
\. Known allergy or hypersensitivity to any of the study drugs
\. 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 only
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