2024-517295-37-00招募中3 期
Prospective multicenter clinical trial for risk estimation and treatment stratification in low and intermediate risk neuroblastoma patients - NB2015-LR
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 29
- 主要终点
- Event-free survival (EFS): Time from diagnosis to event or last follow-up for patients without event; event is defined as death for all reasons, progression and relapse following previous complete remission or secondary malignant disease
研究概览
简要总结
Improvement of event free survival (EFS) of patients with intensified treatment and no impairment of EFS of patients with reduced treatment after treatment allocation by gene expression based risk stratification.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Neuroblastoma diagnosed according to the accepted criteria: histological diagnosis from tumor tissue or presence of distinct neuroblastoma cells in the bone marrow and elevated catecholamine metabolites (HVA, VMA) in blood or urine
- •MYCN not amplified
- •Stage and age either: a. localized neuroblastoma INRGSS stage L1/L2/INSS stage 1-3 and age at diagnosis ≥18 months and < 21 years b. INSS Stage 4S/INRGSS stage MS c. INSS Stage 4/INRGSS stage M and age at diagnosis <18 months d. INRGSS stage L1/L2 and age at first diagnosis <18 months with relapse or progression of neuroblastoma
- •Sufficient tumor tissue available from initial diagnosis available for analysis of RNA expression array
- •Guardians’ informed consent and/ or patient’s informed consent if appropriate according to age and status of psycho-intellectual development
排除标准
- •Participation in other clinical trials
- •History of earlier VOD/SOS of the liver
- •Impaired bone marrow function defined by granulocytes <500/μl and/or thrombocytes <50.000/μl unless clearly caused by bone marrow involvement proven by bone marrow cytology or diffuse abnormal osteomedullary signal in the mIBG scintigraphy
- •HIV infection because of the antiretroviral medication which potentially interferes with the metabolism of the scheduled investigational drugs
- •Pregnancy or lactation
- •Insufficient contraception for sexually active study participants as well as female partners of sexually active male trial participants. Patients must be informed about the need of adequate contraception. Moreover, this need for contraception must be understood by the trial participants. Only contraception with a Pearl index <1% are considered as sufficient. For the purpose of this trial, these are long-term parenteral hormones, progesterone releasing implants, intramuscular progesterone, and intrauterine hormone releasing devices, tubal ligation, and vaginal hormonal contraception. This also holds true for adolescents who are at risk to become sexually active during trial participation
- •Any concomitant non-protocol anticancer therapy
- •Incomplete initial staging
- •Known allergy/hypersensitivity to the scheduled drugs
- •Impaired cardiac function such as insufficiency, heart rate abnormalities and blood pressure abnormalities corresponding to CTCAE 5.0 grade 2 or higher. Hypertension according to age specific reference values clearly due to neuroblastoma is no exclusion criterion
- •Impaired renal function defined by a reduced glomerular filtration rate <30 ml/min*1,73 m2 determined by serum creatinine (Schwartz formula) or serum cystatin C
- •Impaired liver function corresponding to CTCAE 5.0 grade 3 or higher unless liver impairment is clearly caused by neuroblastoma in stage 4S/MS patients. Isolated elevation of the transaminases without evidence of impaired liver function is not an exclusion criterion
结局指标
主要结局
Event-free survival (EFS): Time from diagnosis to event or last follow-up for patients without event; event is defined as death for all reasons, progression and relapse following previous complete remission or secondary malignant disease
Event-free survival (EFS): Time from diagnosis to event or last follow-up for patients without event; event is defined as death for all reasons, progression and relapse following previous complete remission or secondary malignant disease
次要结局
- Overall Survival (OS): Because of the importance for the individual patient OS has been chosen as secondary endpoint.
- Risk factors to impact on EFS and OS: The risk factors age at diagnosis, stage according to INSS and INRG, and copy number alterations of selected genes have been implemented in the INRG classification. These factors will be assessed by multivariate and subgroup analysis. Moreover, the description of patients’ cohorts by these risk factors is mandatory for international comparison of the trial results.
- Response: In neuroblastoma, response to trial treatment is not clearly correlated to outcome. In this trial, response to trial treatment will be compared to historical controls, with a special focus to the cohort with reduced treatment (group C).
- Regression: The percentage of spontaneous regression will be described in patients where the residual primary is observed without cytotoxic treatment and compared to historical controls.
- Incidence rates of toxic events: The administered chemotherapy cycles are known to cause treatment related side effects. To estimate the burden for the patients, kind and intensity of side effects will be compared to historical controls and between the patient groups A-C.
- Additional molecular analysis: The impact of clinical and molecular risk factors such as copy number alterations, telomere maintenance status and mutation status of candidate genes on EFS and OS will be analyzed.
- Group D, relapsed patients: Outcome of patients with relapse or progression of neuroblastoma diagnosed at the age < 18 months with unfavorable classification.
研究者
Clinical trial coordinator
Scientific
University Of Cologne
研究点 (29)
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