EUCTR2006-001489-17-GB进行中（未招募）1 期
High Risk Neuroblastoma Study 1 of SIOP Europe (SIOPEN) - HR-NBL-1 / SIOPE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,230
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Established diagnosis of neuroblastoma according to the International Neuroblastoma Diagnostic Criteria (INSS).
- •Age below 21 years.
- •High Risk Neuroblastoma, defined as either:
- •a)INSS stages 2, 3, 4 or 4s with MYCN amplification, or
- •b)INSS stage 4 without MYCN amplification aged =12 months at diagnosis
- •Patients who have received no previous chemotherapy except for 1 cycle of etoposide and carboplatin (VP/Carbo). In this situation the first COJEC cycle may be replaced by the first cycle of VP/Carbo. Infants awaiting MYCN analysis prior to registration may receive the first cycle of COJEC or etoposide / carboplatin. Any patient who has had rapid COJEC induction chemotherapy according to the protocol can enter the trial providing they are no more than 6 weeks from diagnosis. Any patient who has had one or more cycles of Rapid COJEC or VP/Carbo will receive Rapid COJEC induction and will not be eligible for the R3 randomisation.
- •Written informed consent, including agreement of parents or legal guardian for minors, to enter a randomised study if the criteria for randomisation are met.
- •Tumour cell material available.
- •Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.
- •Registration of all eligibility criteria with the data centre within 6 weeks from diagnosis.
- •Provisional follow up of 5 years.
- •National and local ethical committee approval.
- •Diagnosis of neuroblastoma confirmed.
- •Stage 4; or Stage 4s with MYCN amplification.
- •No prior chemotherapy.
- •Written informed consent to participate in R3 randomisation, and for minors an agreement by parents or legal guardian.
- •Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.
- •All patients must be enrolled on the study and have completed therapy including intensive induction (Rapid COJEC or modified N7) with or without two additional cycles of TVD.
- •BuMel MAT (minor modifications for toxicity concerns) are permitted to render a patient eligible for R2 randomisation, even after more than one line of induction treatment. However, patients must be no more than 9 months from the date of starting the first induction chemotherapy after diagnosis to the date of PBSCR.
- •Complete re-staging, which shows no evidence of progression, following recovery from major transplant related toxicities.
- •Stable WBC above 2 x 109/L (or stable neutrophil count greater than 0.5 x 109/L) in 2 counts taken 48h apart after cessation of G-CSF.
- •Written informed consent to participate in R2 randomisation and for minors an agreement by parents or legal guardian.
- •Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.
- •Radiotherapy must be scheduled to stop at least 7 days prior to the start of immunotherapy.
- •Immunotherapy (starting with week 1 isotretinoin (13-cis-RA)) must start no later than day 120 post PBSCR.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2200
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age r
排除标准
- •Any negative answer concerning the inclusion criteria of the study, R2 and R3 will render the patient ineligible for the corresponding therapy phase.
研究者
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