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

STATUS

Recruiting
End date

Jul 7, 2023
participants needed

500
sponsor

University of Sydney

Send

Updated on 7 December 2021

See if I qualify

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

Condition	Germ Cell Tumors, Germ cell tumor
Treatment	cisplatin, filgrastim, etoposide, Bleomycin (active name: Bleomycin Sulfate), Pegylated G-CSF (Pegfilgrastim)
Clinical Study Identifier	NCT02582697
Sponsor	University of Sydney
Last Modified on	7 December 2021

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

human chorionic gonadotropin

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

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