ACTRN12613000496718招募中3 期
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.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 11 Years 至 45 Years（—）
- 性别
- All
入选标准
- •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.
- •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
排除标准
- •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
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