ACTRN12613000496718
Recruiting
Phase 3
In patients with intermediate and poor-risk metastatic germ cell tumours is an accelerated BEP chemotherapy regimen as good as, or better than, the standard BEP chemotherapy regimen for response rate.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Intermediate and poor-risk metastatic germ cell tumours (GCTs)
- Sponsor
- niversity of Sydney
- Enrollment
- 500
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age greater than or equal to 11 years and less than or equal to 45 years on the date of randomisation
- •2\. Histologically or cytologically confirmed germ cell tumour (non\-seminoma or seminoma), except in the rare case of exceptionally raised tumour markers (AFP greater than or equal to 1000ng/mL and/or beta\-HCG greater than or equal to 5000 IU/L) without histologic or cytologic confirmation 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 modified IGCCC classification (modified with different LDH criteria for intermediate risk non\-seminoma, and inclusion of ovarian primaries).
- •6\. Adequate bone marrow function with ANC greater than or equal to 1\.0 x 10^9/L, Platelet count greater than or equal to 100 x 10^9/L
- •7\. Adequate liver function where bilirubin must be less than or equal to 1\.5 x ULN, ALT and AST must be less than or equal to 2\.5 x ULN; except if the elevations are due to hepatic metastases, in which case ALT and AST must be less than or equal to 5 x ULN
- •8\. Adequate renal function of GFR greater than or equal to 60 ml/min. It is recommended that GFR is estimated with the Cockcroft\-Gault formula, unless calculated to be less than 60 ml/min or borderline in which case by 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.
Exclusion Criteria
- •1\. History of a malignancy prior to registration except for germ cell tumour or non\-melanomatous carcinoma of the skin
- •2\. Previous chemotherapy or radiotherapy, except (a)participants with pure seminoma relapsing after radiotherapy or adjuvant chemotherapy with 1\-2 doses of single agent carboplatin, (b)participants with NSGCT and poor prognosis by IGCCC criteria receiving pre\-protocol chemotherapy (eg. low\-dose platinum and etoposide, baby\-BOP) , (c)Participants who need to start therapy urgently prior to completing study\-specific baseline investigations may commence study chemotherapy prior to registration and randomisation.
- •3\. Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
- •4\. Significant co\-morbid respiratory disease that contraindicates the use of Bleomycin
- •5\. Peripheral neuropathy greater than or equal to grade 2 or clinically significant sensori\-neural 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 have been surgically sterilised or use a double barrier method of contraception
- •8\. Known allergy or hypersensitivity to any of the study drugs
- •9\. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow\-up schedule, including alcohol dependence or drug abuse
Outcomes
Primary Outcomes
Not specified
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