2023-508926-91-00招募中3 期
Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, standard arm) with upfront Vincristine, Carboplatin and Etoposide (VCE, experimental arm)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- GPOH gGmbH
- 入组人数
- 307
- 试验地点
- 93
- 主要终点
- Percentage of patients with radiologic complete response (CR) of any metastasis and/or Very Good Partial Response (VGPR) of lung metastasis of childhood renal tumours after 6 weeks of preoperative chemotherapy (Section 12.5 for definitions of metastatic response)
研究概览
简要总结
To determine non-inferiority of preoperative 6 weeks of VCE to VAD in the overall metastatic rapid response rate (MetRR) in newly diagnosed stage 4 childhood renal tumours. The MetRR will include the pulmonary response rate (PRR) and the response rate on non-pulmonary metastasis (NPRR).
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Age <18 years >3 months
- •Patient suffering from metastatic renal tumour at initial diagnosis having at least one circumscript, non-calcified (pulmonary) nodule (or other lesion highly suspicious of metastasis according to criteria for metastatic disease) ≥3 mm as determined by chest CT-scan and abdominal CT-scan/MRI. Metastatic disease must be confirmed by central review.
- •Understand and voluntarily provide permission (subjects and when applicable, parental/legal representative(s)) to the ICF prior to conducting any study related assessments/procedures
- •Able to adhere to the study visit schedule and other protocol requirements
- •No pre-existing and ongoing cardiac malfunction disease
- •No pre-existing and ongoing liver function deficiency which is not controllable by substitution
- •Metastatic childhood renal tumour must be confirmed by central review.
排除标准
- •Patient and/or parental/legal representative(s) denied randomization
- •pre-existing health impairment that significantly hazards the safe treatment according to the study
- •unwillingness to follow adequate supportive measures including transfusion of blood products if medically needed
- •inability to receive chemotherapy according to the protocol, this is particulary true for: a. acute kidney failure needing dialysis treatment b. pre-existing peripheral neuropathy
- •Active, uncontrolled life threatening Infection (e.g. Acute Hepatitis, Pneumonia, AIDS, Varizella)
- •known chromosomal instability/susceptibility (e.g. Fanconi Anemia, Nijmegen Breakage Syndrome)
- •participation in other interventional trials (registration in observational noninterventional studies is acceptable)
- •age at start of treatment <3 months or >18 years
- •any other medical condition incompatible with the protocol treatment
- •primary nephrectomy
- •inability to be followed until two years after treatment
- •other chemotherapy prior to enrolment
- •other histology than nephroblastoma at diagnosis
- •Pregnancy or lactating
- •Fertile female with child bearing potential and fertile male subjects who deny the use of highly effective contraceptive measures
- •Treated by any investigational agent in a clinical study within previous 4 weeks
- •Hypersensitivity to the active substances or other excipients contained in the investigational medical products listed in the summary of product characteristics (SmPC) or Investigators Brochure (IB).
结局指标
主要结局
Percentage of patients with radiologic complete response (CR) of any metastasis and/or Very Good Partial Response (VGPR) of lung metastasis of childhood renal tumours after 6 weeks of preoperative chemotherapy (Section 12.5 for definitions of metastatic response)
Percentage of patients with radiologic complete response (CR) of any metastasis and/or Very Good Partial Response (VGPR) of lung metastasis of childhood renal tumours after 6 weeks of preoperative chemotherapy (Section 12.5 for definitions of metastatic response)
次要结局
- Percentage of patients after 6 weeks of preoperative chemotherapy achieving a CR after surgery of metastasis at time of nephrectomy
- Percentage of patients with complete response +/- VGPR of (pulmonary) metastasis of nephroblastoma after 6 weeks of preoperative chemotherapy + 9 weeks adjuvant chemotherapy.
- Percentage of patients with complete response +/- VGPR of (pulmonary) metastasis of nephroblastoma after preoperative chemotherapy + 9 weeks adjuvant chemotherapy + metastasectomy
- Percentage of patients with remaining metastatic disease after surgery that achieve a CR at week 9 of adjuvant chemotherapy
- Percentage of patients with complete response +/- VGPR of (pulmonary) metastasis of nephroblastoma at the end of adjuvant chemotherapy ± metastasectomy ± RT
- Percentage of patients with radiologic complete response (CR) of any metastasis or Very Good Partial Response (VGPR) of lung metastasis of nephroblastoma after 6 weeks of preoperative chemotherapy
- Primary tumour volume shrinkage after 6 weeks of preoperative chemotherapy
- Primary tumour volume after 6 weeks of preoperative chemotherapy
- Number of metastases at diagnosis and after preoperative treatment
- Maximum diameters of the largest metastases at diagnosis and after preoperative treatment
- Stage distribution of local tumour
- Histologic subtype distribution of local tumour (LR, IR, HR)
- Histologic subtype distribution of resected nodules/metastasis (LR, IR, HR)
- Percentage of blastema and blastemal residual volume in local tumour
- Percentage of patients with <10 ml of blastemal residual volume in resected nephroblastoma after 6 weeks of preoperative chemotherapy
- Percentage of necrosis in local tumour
- Percentage of patients with complete necrosis in resected nodules
- Percentage of patients with 1q gain being in CR/VGPR in both arms.
- Percentage of patients requiring pulmonary radiotherapy in first line
- Percentage of patients suffering Grade 3 or 4 ALAT or bilirubin increase during preoperative treatment
- Percentage of patients suffering from SOS during preoperative treatment according to EBMT criteria
- Percentage of patients suffering any Grade 4 or grade 5 toxicity during preoperative chemotherapy
- Overall duration of preoperative treatment per arm as determined as interval D1 – date of nephrectomy
- Delay in timing of nephrectomy: % of patients with more than 8 weeks since start of preoperative chemotherapy because of toxicity
- Percentage of (peri-)operative complications (haemorrhage, rupture, thromboembolism)
- Event-free survival at 2 and 5 years for the whole cohort and according to study arm (VAD/VCE) and according to 1qGain
- Overall survival at 2 and 5 years for the whole cohort and according to study arm (VAD/VCE) and according to 1qGain
研究者
Prof. Rhoikos Furtwängler
Scientific
GPOH gGmbH
研究点 (93)
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